OsteoarthritisPhase 3NCT03031938
Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
A Phase 3 study testing Investigational medical product (IMP) administered in parent study in people with Osteoarthritis and Cancer Pain, run by Pfizer at 6 sites in United States.
Trial summary
A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb… Read more about this study
- Who is it for?
- Ages 0 years to 2 months
- Conditions the study is for
- Osteoarthritis, Cancer Pain, Recurrent Low Back Pain
- What is being tested?
- Investigational medical product (IMP) administered in parent study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Nov 2017to 4 Jun 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study.
- The infant's mother (who was the tanezumab clinical study participant) must review, agree and sign an informed consent document explaining the details of the perinatal and post natal follow up. Where local regulations mandate, the male parent would also review and sign the informed consent.
- Parents or legal guardian must be willing and able to comply with scheduled visits and study procedures.
Who cannot join
- There are no exclusion criteria for participating in this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Lafayette Clinical Research Group
Lafayette, Indiana, 47905
Preferred Pediatrics
Lafayette, Indiana, 47905
USC Keck School of Medicine
Los Angeles, California, 90033
Gulfcoast Research Institute
Sarasota, Florida, 34232
Kennedy and White Orthopaedic Center
Sarasota, Florida, 34232
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, 33609
About this study
Official title: A PROTOCOL TO MONITOR FROM BIRTH TO AGE 15 MONTHS THE NEUROLOGICAL DEVELOPMENT OF INFANTS WITH EXPOSURE IN-UTERO IN TANEZUMAB CLINICAL STUDIES AT ALL INVESTIGATIONAL SITES
A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb study.
Read the detailed description
A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063
- Conditions
- Osteoarthritis, Cancer Pain, Recurrent Low Back Pain
- Being tested
- Investigational medical product (IMP) administered in parent study
- Keywords
- Exposure in utero in tanezumab program
- Medical subject headings
- Osteoarthritis, Cancer Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational medical product (IMP) administered in parent studyDrug
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Long term observational study of subjects from tanezumab parent study Receives: Drug: Investigational medical product (IMP) administered in parent study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Measured: Any visit during participants' age from 0 to 2 Months
Occipital-frontal Head Circumference at 8 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Measured: At 8 Months of participants' age
Occipital-frontal Head Circumference at 15 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Measured: At 15 Months of participants' age
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Measured: Any visit during participants' age from 0 to 3 Months
Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Measured: Any visit during participants' age above 3 Months and up to 6 Months
Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Measured: Any visit during participants' age above 6 Months and up to 9 Months
Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Measured: Any visit during participants' age above 15 Months and up to 18 Months
Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Measured: Any visit during participants' age above 21 Months and up to 24 Months
Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age
Occipital-frontal head circumference of participants in cm was reported.
Measured: Any visit during participants' age above 24 Months and up to 30 Months
Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Body length of participants in cm was reported.
Measured: Any visit during participants' age from 0 to 2 Months
Body Length at 8 Months of Participant's Age
Body length of participants in cm was reported.
Measured: At 8 Months of participant's age
Body Length at 15 Months of Participant's Age
Body length of participants in cm was reported.
Measured: At 15 Months of participant's age
Body Length During 0 to <=3 Months of Participant's Age
Body length of participants in cm was reported.
Measured: Any visit during participants' age from 0 to 3 Months
Body Length During >3 to <=6 Months of Participant's Age
Body length of participants in cm was reported.
Measured: Any visit during participants' age above 3 Months and up to 6 Months
Body Length During >6 to <=9 Months of Participant's Age
Body length of participants in cm was reported.
Measured: Any visit during participants' age above 6 Months and up to 9 Months
Body Length During >15 to <=18 Months of Participant's Age
Body length of participants in cm was reported.
Measured: Any visit during participants' age above 15 Months and up to 18 Months
Body Length During >21 to <=24 Months of Participant's Age
Body length of participants in cm was reported.
Measured: Any visit during participants' age above 21 Months and up to 24 Months
Body Length During >24 to <=30 Months of Participant's Age
Body length of participants in cm was reported.
Measured: Any visit during participants' age above 24 Months and up to 30 Months
Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Measured: Any visit during participants' age from 0 to 2 Months
Body Weight at 8 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Measured: At 8 Months of participants' age
Body Weight at 15 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Measured: At 15 Months of participants' age
Body Weight During 0 to <=3 Months of Participant's Age
Body weight of participants in kilogram (kg) was reported.
Measured: Any visit during participants' age from 0 to 3 Months
Body Weight During >3 to <=6 Months of Participant's Age
Body weight of participants in kg was reported.
Measured: Any visit during participants' age above 3 Months and up to 6 Months
Body Weight During >6 to <=9 Months of Participant's Age
Body weight of participants in kg was reported.
Measured: Any visit during participants' age above 6 Months and up to 9 Months
Body Weight During >15 to <=18 Months of Participant's Age
Body weight of participants in kg was reported.
Measured: Any visit during participants' age above 15 Months and up to 18 Months
Body Weight During >21 to <=24 Months of Participant's Age
Body weight of participants in kg was reported.
Measured: Any visit during participants' age above 21 Months and up to 24 Months
Body Weight During >24 to <=30 Months of Participant's Age
Body weight of participants in kg was reported.
Measured: Any visit during participants' age above 24 Months up to 30 Months
Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Measured: Any visit during participants' age from 0 to 2 Months
Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Measured: At 8 Months of participants' age
Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Measured: At 15 Months participants' age
Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Measured: Any visit during participants' age from 0 to 3 Months
Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Measured: Any visit during participants' age above 3 Months and up to 6 Months
Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Measured: Any visit during participants' age above 6 Months and up to 9 Months
Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Measured: Any visit during participants' age above 15 Months and up to 18 Months
Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Measured: Any visit during participants' age above 21 Months and up to 24 Months
Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age
Systolic and diastolic blood pressure of participants in mmHg was reported.
Measured: Any visit during participants' age above 24 Months and up to 30 Months
Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Measured: Any visit during participants' age from 0 to 2 Months
Pulse Rate at 8 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Measured: At 8 Months of participants' age
Pulse Rate at 15 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Measured: At 15 Months of participants' age
Pulse Rate During 0 to <=3 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Measured: Any visit during participants' age from 0 to 3 Months
Pulse Rate During >3 to <=6 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Measured: Any visit during participants' age above 3 Months and up to 6 Months
Pulse Rate During >6 to <=9 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Measured: Any visit during participants' age above 6 Months and up to 9 Months
Pulse Rate During >15 to <=18 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Measured: Any visit during participants' age above 15 Months and up to 18 Months
Pulse Rate During >21 to <=24 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Measured: Any visit during participants' age above 21 Months and up to 24 Months
Pulse Rate During >24 to <=30 Months of Participant's Age
Pulse rate of participants in beats per minute was reported.
Measured: Any visit during participants' age above 24 Months and up to 30 Months
Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Measured: Any visit during participants' age from 0 to 2 Months
Temperature at 8 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Measured: At 8 Months of participants' age
Temperature at 15 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Measured: At 15 Months of participants' age
Temperature During 0 to <=3 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Measured: Any visit during participants' age from 0 to 3 Months
Temperature During >3 to <=6 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Measured: Any visit during participants' age above 3 Months and up to 6 Months
Temperature During >6 to <=9 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Measured: Any visit during participants' age above 6 Months and up to 9 Months
Temperature During >15 to <=18 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Measured: Any visit during participants' age above 15 Months and up to 18 Months
Temperature During >21 to <=24 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Measured: Any visit during participants' age above 21 Months and up to 24 Months
Temperature During >24 to <=30 Months of Participant's Age
Temperature of participants in degree Celsius was reported.
Measured: Any visit during participants' age above 24 Months and up to 30 Months
Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Measured: Any visit during participants' age from 0 to 2 Months
Respiratory Rate at 8 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Measured: At 8 Months of participants' age
Respiratory Rate at 15 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Measured: At 15 Months participants' age
Respiratory Rate During 0 to <=3 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Measured: Any visit during participants' age from 0 to 3 Months
Respiratory Rate During >3 to <=6 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Measured: Any visit during participants' age above 3 Months and up to 6 Months
Respiratory Rate During >6 to <=9 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Measured: Any visit during participants' age above 6 Months and up to 9 Months
Respiratory Rate During >15 to <=18 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Measured: Any visit during participants' age above 15 Months and up to 18 Months
Respiratory Rate During >21 to <=24 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Measured: Any visit during participants' age above 21 Months and up to 24 Months
Respiratory Rate During >24 to <=30 Months of Participant's Age
Respiratory rate of participants in breaths per minute was reported.
Measured: Any visit during participants' age above 24 Months and up to 30 Months
Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Measured: Any visit during participants' age from 0 to 2 Months
Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Measured: At 8 Months of participants' age
Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Measured: At 15 Months of participants' age
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Measured: Follow-up Visit 1 (At the age of Month 20)
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Measured: Follow-up Visit 2 (At the age of 26 Months)
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Measured: At 8 Months of participants' age
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Measured: At 15 Months of participants' age
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Measured: Follow-up Visit 1 (At the age of Month 20)
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.
Measured: Follow-up Visit 2 (At the age of Month 26)
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Measured: At 8 Months of participants' age
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Measured: At 15 Months of participants' age
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 1 (Month 20 of Participant's Age)
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Measured: Follow-up Visit 1 (At the age of Month 20)
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 2 (Month 26 of Participant's Age)
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Measured: Follow-up Visit 2 (At the age of Month 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start3 Nov 2017
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031938
- Sponsor's protocol ID
- A4091065
- Other IDs
- 2013-002548-10, INFANT SAFETY FOLLOW-UP #2, NEONATAL MONITORING STUDY #2
- Status last verified
- Jun 2021
- First submitted
- 17 Jan 2017
- Last updated
- 25 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROTOCOL TO MONITOR FROM BIRTH TO AGE 15 MONTHS THE NEUROLOGICAL DEVELOPMENT OF INFANTS WITH EXPOSURE IN-UTERO IN TANEZUMAB CLINICAL STUDIES AT ALL INVESTIGATIONAL SITES
- ClinicalTrials.gov ID
- NCT03031938
- Acronym / sponsor ID
- A4091065
- Conditions
- Osteoarthritis, Cancer Pain, Recurrent Low Back Pain
- Keywords
- Exposure in utero in tanezumab program
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Posted 25 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb study.
Detailed description
A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: Investigational medical product (IMP) administered in parent studyLong term observational study of subjects from tanezumab parent study |
Who may qualify
- Ages
- 0 years to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study.
- The infant's mother (who was the tanezumab clinical study participant) must review, agree and sign an informed consent document explaining the details of the perinatal and post natal follow up. Where local regulations mandate, the male parent would also review and sign the informed consent.
- Parents or legal guardian must be willing and able to comply with scheduled visits and study procedures.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for participating in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational medical product (IMP) administered in parent studyIMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study | Drug | Cohort 1 |
Primary outcome
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 2 Months
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Occipital-frontal Head Circumference at 8 Months of Participant's Age
Time frame: At 8 Months of participants' age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Occipital-frontal Head Circumference at 15 Months of Participant's Age
Time frame: At 15 Months of participants' age
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 3 Months
Occipital-frontal head circumference of participants in centimeter (cm) was reported.
Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Occipital-frontal head circumference of participants in cm was reported.
Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Occipital-frontal head circumference of participants in cm was reported.
Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 2 Months
Body length of participants in cm was reported.
Body Length at 8 Months of Participant's Age
Time frame: At 8 Months of participant's age
Body length of participants in cm was reported.
Body Length at 15 Months of Participant's Age
Time frame: At 15 Months of participant's age
Body length of participants in cm was reported.
Body Length During 0 to <=3 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 3 Months
Body length of participants in cm was reported.
Body Length During >3 to <=6 Months of Participant's Age
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Body length of participants in cm was reported.
Body Length During >6 to <=9 Months of Participant's Age
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Body length of participants in cm was reported.
Body Length During >15 to <=18 Months of Participant's Age
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Body length of participants in cm was reported.
Body Length During >21 to <=24 Months of Participant's Age
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Body length of participants in cm was reported.
Body Length During >24 to <=30 Months of Participant's Age
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Body length of participants in cm was reported.
Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 2 Months
Body weight of participants in kilogram (kg) was reported.
Body Weight at 8 Months of Participant's Age
Time frame: At 8 Months of participants' age
Body weight of participants in kilogram (kg) was reported.
Body Weight at 15 Months of Participant's Age
Time frame: At 15 Months of participants' age
Body weight of participants in kilogram (kg) was reported.
Body Weight During 0 to <=3 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 3 Months
Body weight of participants in kilogram (kg) was reported.
Body Weight During >3 to <=6 Months of Participant's Age
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Body weight of participants in kg was reported.
Body Weight During >6 to <=9 Months of Participant's Age
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Body weight of participants in kg was reported.
Body Weight During >15 to <=18 Months of Participant's Age
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Body weight of participants in kg was reported.
Body Weight During >21 to <=24 Months of Participant's Age
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Body weight of participants in kg was reported.
Body Weight During >24 to <=30 Months of Participant's Age
Time frame: Any visit during participants' age above 24 Months up to 30 Months
Body weight of participants in kg was reported.
Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 2 Months
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age
Time frame: At 8 Months of participants' age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age
Time frame: At 15 Months participants' age
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 3 Months
Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.
Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Systolic and diastolic blood pressure of participants in mmHg was reported.
Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Systolic and diastolic blood pressure of participants in mmHg was reported.
Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Systolic and diastolic blood pressure of participants in mmHg was reported.
Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Systolic and diastolic blood pressure of participants in mmHg was reported.
Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Systolic and diastolic blood pressure of participants in mmHg was reported.
Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 2 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate at 8 Months of Participant's Age
Time frame: At 8 Months of participants' age
Pulse rate of participants in beats per minute was reported.
Pulse Rate at 15 Months of Participant's Age
Time frame: At 15 Months of participants' age
Pulse rate of participants in beats per minute was reported.
Pulse Rate During 0 to <=3 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 3 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >3 to <=6 Months of Participant's Age
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >6 to <=9 Months of Participant's Age
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >15 to <=18 Months of Participant's Age
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >21 to <=24 Months of Participant's Age
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Pulse rate of participants in beats per minute was reported.
Pulse Rate During >24 to <=30 Months of Participant's Age
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Pulse rate of participants in beats per minute was reported.
Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 2 Months
Temperature of participants in degree Celsius was reported.
Temperature at 8 Months of Participant's Age
Time frame: At 8 Months of participants' age
Temperature of participants in degree Celsius was reported.
Temperature at 15 Months of Participant's Age
Time frame: At 15 Months of participants' age
Temperature of participants in degree Celsius was reported.
Temperature During 0 to <=3 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 3 Months
Temperature of participants in degree Celsius was reported.
Temperature During >3 to <=6 Months of Participant's Age
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Temperature of participants in degree Celsius was reported.
Temperature During >6 to <=9 Months of Participant's Age
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Temperature of participants in degree Celsius was reported.
Temperature During >15 to <=18 Months of Participant's Age
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Temperature of participants in degree Celsius was reported.
Temperature During >21 to <=24 Months of Participant's Age
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Temperature of participants in degree Celsius was reported.
Temperature During >24 to <=30 Months of Participant's Age
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Temperature of participants in degree Celsius was reported.
Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 2 Months
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate at 8 Months of Participant's Age
Time frame: At 8 Months of participants' age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate at 15 Months of Participant's Age
Time frame: At 15 Months participants' age
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During 0 to <=3 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 3 Months
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >3 to <=6 Months of Participant's Age
Time frame: Any visit during participants' age above 3 Months and up to 6 Months
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >6 to <=9 Months of Participant's Age
Time frame: Any visit during participants' age above 6 Months and up to 9 Months
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >15 to <=18 Months of Participant's Age
Time frame: Any visit during participants' age above 15 Months and up to 18 Months
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >21 to <=24 Months of Participant's Age
Time frame: Any visit during participants' age above 21 Months and up to 24 Months
Respiratory rate of participants in breaths per minute was reported.
Respiratory Rate During >24 to <=30 Months of Participant's Age
Time frame: Any visit during participants' age above 24 Months and up to 30 Months
Respiratory rate of participants in breaths per minute was reported.
Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age
Time frame: Any visit during participants' age from 0 to 2 Months
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age
Time frame: At 8 Months of participants' age
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age
Time frame: At 15 Months of participants' age
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)
Time frame: Follow-up Visit 1 (At the age of Month 20)
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)
Time frame: Follow-up Visit 2 (At the age of 26 Months)
Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age
Time frame: At 8 Months of participants' age
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age
Time frame: At 15 Months of participants' age
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)
Time frame: Follow-up Visit 1 (At the age of Month 20)
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.
Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)
Time frame: Follow-up Visit 2 (At the age of Month 26)
BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age
Time frame: At 8 Months of participants' age
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age
Time frame: At 15 Months of participants' age
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 1 (Month 20 of Participant's Age)
Time frame: Follow-up Visit 1 (At the age of Month 20)
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 2 (Month 26 of Participant's Age)
Time frame: Follow-up Visit 2 (At the age of Month 26)
REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: <70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and >130 (very superior). Higher scores indicated better language ability.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational medical product (IMP) administered in parent study in people with Osteoarthritis and Cancer Pain, run by Pfizer at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age (time frame: Any visit during participants' age from 0 to 2 Months). The study lists 76 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.