Infant Developmental AssessmentNCT01362660
A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
An observational study of Infant Developmental Assessment, run by Pfizer at 8 sites in United States.
Trial summary
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study). Read more about this study
- Who is it for?
- Ages Up to 15 months
- Conditions the study is for
- Infant Developmental Assessment
- What is being tested?
- Unintentional exposure in utero
- How many people
- 7 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 15 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants with potential exposure in utero through their parents partcipation in a tanezumab clinical study
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 through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.
Who cannot join
- There are no exclusion criteria for this study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Pfizer Investigational Site
Cutler Bay, Florida, 33189
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Houston, Texas, 77065
Pfizer Investigational Site
Memphis, Tennessee, 38119-5214
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
Tempe, Arizona, 85282
Pfizer Investigational Site
Tempe, Arizona, 85283
Pfizer Investigational Site
Wildomar, California, 92595
About this study
Official title: A Protocol to Monitor the Neurological Development of Infants With Exposure In-utero From Birth to Aged 15 Months in Tanezumab Clinical Studies at Investigational Sites Overseen by Schulman and Associates Institutional Review Board
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).
Read the detailed description
This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.
- Conditions
- Infant Developmental Assessment
- Being tested
- Unintentional exposure in utero
- Keywords
- post-natal monitoring, exposure in utero
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unintentional exposure in uteroOther
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).
| Study group | Role | What they receive |
|---|---|---|
| Infants with potential exposure in utero | Not described Receives: Other: Unintentional exposure in utero |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Infant Neurodevelopmental Screener
Measured: 0-2 Months
Bayley Infant Neurodevelopmental Screener
Measured: 8 months
Bayley Infant Neurodevelopmental Screener
Measured: 15 months
Receptive-Expressive Emergent Language Test
Measured: 0-2 Months
Receptive-Expressive Emergent Language Test
Measured: 8 months
Receptive-Expressive Emergent Language Test
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Developmental AssessmentStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362660
- Sponsor's protocol ID
- A4091055
- Other IDs
- NEONATAL MONITORING
- Status last verified
- Feb 2013
- First submitted
- 24 May 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol to Monitor the Neurological Development of Infants With Exposure In-utero From Birth to Aged 15 Months in Tanezumab Clinical Studies at Investigational Sites Overseen by Schulman and Associates Institutional Review Board
- ClinicalTrials.gov ID
- NCT01362660
- Acronym / sponsor ID
- A4091055
- Conditions
- Infant Developmental Assessment
- Keywords
- post-natal monitoring, exposure in utero
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).
Detailed description
This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with potential exposure in utero | – | Other: Unintentional exposure in utero |
Who may qualify
- Ages
- Up to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with potential exposure in utero through their parents partcipation in a tanezumab clinical study
Key inclusion criteria (1 listed)
- Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for 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 |
|---|---|---|
| Unintentional exposure in uteroThis study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study). | Other | Infants with potential exposure in utero |
Primary outcome
Bayley Infant Neurodevelopmental Screener
Time frame: 0-2 Months
Bayley Infant Neurodevelopmental Screener
Time frame: 8 months
Bayley Infant Neurodevelopmental Screener
Time frame: 15 months
Receptive-Expressive Emergent Language Test
Time frame: 0-2 Months
Receptive-Expressive Emergent Language Test
Time frame: 8 months
Receptive-Expressive Emergent Language Test
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Developmental Assessment, run by Pfizer at 8 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 1 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 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bayley Infant Neurodevelopmental Screener (time frame: 0-2 Months). The study lists 6 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 6 Feb 2013.