Rhinitis, Allergic, PerennialPhase 4NCT00449072
Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)
A Phase 4 study testing TAA-AQ, Nasacort® AQ and Claritin® in people with Rhinitis, Allergic, Perennial, run by Sanofi at 1 site in United States.
Trial summary
The primary objective of the study was to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo (NASACORT® AQ placebo group) for… Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- TAA-AQ, Nasacort® AQ and Claritin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Oct 2011
- Phase
- Phase 4
- 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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male participants [3 years to <= 9 years + 0 days old] at Visit 1 and no older than [9 years + 120 days] at Visit 3; and, female participants [3 years to <= 8 years + 0 days old] at Visit 1 and no older than [8 years + 120 days] at Visit 3: all sexually prepubertal (ie, Stage 1 of Tanner Classification of sexual maturity) at Visit 1 and Visit 3. A 5-day extension to the age upper bound was permitted under certain circumstances to enable scheduling of Visits 1 and 3
- At least a one year history of PAR as assessed and documented by the investigator (with or without seasonal allergic rhinitis [SAR])
- Positive skin test (prick or intradermal) to a perennial allergen that was present in the participant's environment. A skin test was considered positive if the wheal produced by the allergen was equal to or greater than that caused by positive control (histamine) or was at least 3 mm (prick test) or 7 mm (intradermal test) greater than the wheal of negative control (saline). If a skin test could not be performed, the radioallergosorbent test (RAST) would be used as an alternative. Documented historical skin testing or RAST performed during the past year were acceptable
- Height within the 3rd and 97th percentiles at screening (Visit 1), Visit 2, and at randomization (Visit 3)
- Symptomatic (daily AM instantaneous total nasal symptom score was >= 4 out of 12) on any 4 out of the last 7 consecutive days immediately prior to and including the morning of Visit 3. Symptom ratings were to be completed with the help of a parent/guardian/caregiver
- Written informed consent and ability of parent or legal guardian of the participant to give a written informed consent before any study related procedures. Participants 7 years of age and older must have provided a signed assent form
- Participants had to be toilet-trained
Who cannot join
- Gross nasal anatomical deformities including large polyposis and marked deviated septum
- History of or current cataract or glaucoma
- History of hypersensitivity to the corticosteroids or to any excipient of the investigational product
- Participant was the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- Height, weight, or body mass index (BMI)-for-age below the 3rd or above the 97th percentile at Visits 1, 2, or 3
- Treatment with systemic corticosteroids (oral, intravenous, intramuscular, or intra-articular) within 3 months prior to Visit 1
Show all 18Show fewer
- Treatment with systemic corticosteroids for >2 courses received up to 1 year before Visit 1 was exclusionary. Up to 2 courses of systemic corticosteroids each course not exceeding 14 days up to 1 year before Visit 1 was allowed.
- Treatment with inhaled, intranasal, or high potency topical corticosteroid exposure within 6 weeks prior to Visit 1. Mild asthma that was well-controlled and without the use of inhaled corticosteroids within 6 weeks before screening (Visit 1).
- Immunotherapy, except stable (>=1 month) maintenance schedule before Visit 1.
- Treatment with any substance before Visit 1 that might have affected growth velocity and/or linear growth, such as, but not be limited to methylphenidate hydrochloride, thyroid hormone, growth hormone, anabolic steroids, calcitonin, estrogens, progestins, bisphosphonates, anticonvulsants, or phosphate-binding antacids
- Treatment with any investigational product or device in the 30 days before Visit 1 or at any time throughout the duration of this trial (Visit 1 through Visit 11).
- Bone age as assessed by X-ray of the left hand and wrist that was outside +/- 1.5 years of participants chronological age at Visit 2. Right hand and wrist were to be radiographed in the event of bone injury to the left hand or wrist.
- Unresolved upper respiratory tract infection, sinus infection or nasal candidiasis (i.e., symptomatic or under treatment) within the last 2 weeks before Visit 3.
- Participants or parent/guardian/caregiver unable to demonstrate correct administration of the investigational product at Visit 1.
- Concomitant disease other than PAR which could have interfered with the study procedures or outcomes as determined by the investigator.
- History of hospitalization due to asthma within 1 year before screening (Visit 1).
- Abnormal 24-hour urinary free cortisol level assessed at screening (Visit 2).
- The above information was not intended to contain all considerations relevant to potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Group Study of the 12 Month Effect of Treatment With Once Daily Triamcinolone Acetonide (NASACORT® AQ Nasal Spray 110 μg) on the Growth Velocity of Children, 3 to 9 Years of Age, With Perennial Allergic Rhinitis (PAR)
The primary objective of the study was to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo (NASACORT® AQ placebo group) for 12-months.
The secondary objectives were to compare the following in prepubertal participants treated with TAA nasal spray versus placebo:
- the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure the Hypothalamic-Pituitary Adrenal [HPA] axis function)
- the rate of treatment-emergent-adverse-events (TEAE)
- global efficacy rated by the investigator and the participant separately
- the rate of use of rescue medication during the study
Read the detailed description
The study consisted of:
- a 4- to 6-month screening/baseline period
- a 12-month (up to Day 360+/-5 days) double-blind treatment period starting on Day 1
- a 2-month follow-up period (up to Day 420+/-5 days)
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Placebo, TAA-AQ, Nasacort® AQ, Claritin®
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration
PlaceboOther
Placebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period
TAA-AQ, Nasacort® AQDrug
110 μg TAA-AQ was administered once daily intranasally (1 spray delivering 55 μg of TAA-AQ in each nostril) during the double-blind treatment period
Claritin®Drug
Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used throughout the study on an as needed basis according to the Food and Drug Administration-approved manufacturer's label
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered
* Placebo in the baseline/screening period to demonstrate administration of investigational product (IP) with the nasal spray bottle
* Placebo in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication. Receives: Other: Placebo; Drug: Claritin® |
| TAA-AQ | Active comparator | 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered
* Placebo in the baseline/screening period to demonstrate administration of IP with the nasal spray bottle
* Triamcinolone acetonide (TAA-AQ) in the double-blind treatment period
All participants were provided Children's Claritin® Syrup as a rescue medication. Receives: Other: Placebo; Drug: TAA-AQ, Nasacort® AQ; Drug: Claritin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Velocity
Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time.
Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing.
Measured: Day 1 to end of treatment (Day 360)
Secondary outcomes (9)
Change From Baseline in Instantaneous Total Nasal Symptom Score (TNSS)
PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:
- 0 = symptom absent
- 1 = mild (present but not annoying to self)
- 2 = moderate (annoying to self but not interfering with sleep or daily living)
- 3 = severe (interfered with daily living and/or sleep)
TNSS was the sum of the individual symptom scores (ranging 0-3), and TNSS ranged from 0 (best outcome) to 12 (worst outcome). A negative value for change represents an improvement in symptoms.
Measured: For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)
Change From Baseline in Four Individual Nasal Symptom Scores at the End of Treatment
PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:
- 0 = symptom absent
- 1 = mild (present but not annoying to self)
- 2 = moderate (annoying to self but not interfering with sleep or daily living)
- 3 = severe (interfered with daily living and/or sleep)
Individual symptom scores ranged from 0 (best outcome) to 3 (worst outcome). A negative value for change represents an improvement in symptoms.
Measured: For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)
Global Efficacy as Assessed by the Participant (With the Help of a Parent/Guardian/Caregiver) During and at the End of the Double-blind Treatment Period
Global efficacy was assessed by the participant (with the help of a parent/guardian/caregiver) using the following scale:
- 0 = no relief (symptoms unchanged or worse than before)
- 1 = slight relief (symptoms were present and only minimally improved)
- 2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)
- 3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)
- 4 = complete relief (virtually no symptom present)
Measured: Day 120, Day 240 and Day 360
Global Efficacy as Assessed by the Investigator During and at the End of the Double-blind Treatment Period
Global efficacy was assessed by the investigator using the following scale:
- 0 = no relief (symptoms unchanged or worse than before)
- 1 = slight relief (symptoms were present and only minimally improved)
- 2 = moderate relief (symptoms were present and could have been troublesome but were noticeably improved)
- 3 = marked relief (symptoms were greatly improved and although present were scarcely troublesome)
- 4 = complete relief (virtually no symptom present)
Measured: Day 120, Day 240 and Day 360
Percentage of Participants Who Used the Rescue Medication During the Double-blind Phase of the Study
Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.
The percentage of participants who used the rescue medication during each of the study periods is reported.
Measured: Baseline (4-6 months before Day 1), double-blind treatment period (Day 1 to Day 360) and follow-up (Day 361 to Day 420)
Percentage of Days Participants Used the Rescue Medication During the Double-blind Treatment Phase of the Study
Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary.
The percentage of days that participants used the rescue medication during the double-blind treatment phase of the study.
Measured: double-blind treatment period (Day 1 to Day 360)
24 Hour Urinary Free Cortisol Levels
Urine cortisol levels was determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours].
Measured: Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)
24 Hour Cortisol/Creatinine Ratio
Urine cortisol and creatinine levels were determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours]. No normal range is available for cortisol/creatinine ratio.
Measured: Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Adverse events that developed, worsened, or became serious during the double-blind treatment period or within 7 days after the last dose of double-blind investigational product (IP) are defined as TEAEs.
A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:
- Resulted in death
- Was life-threatening
- Required inpatient hospitalization or prolongation of existing hospitalization
- Resulted in persistent or significant disability/incapacity
- Was a congenital anomaly/birth defect
- Was a medically important event
Measured: From Day 1 to 7 days following end of treatment (Day 360)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2011
- Study completionOct 2011
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 Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akbar Akbary, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449072
- Sponsor's protocol ID
- XRG5029C_3503
- Status last verified
- Oct 2011
- First submitted
- 15 Mar 2007
- Last updated
- 10 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Group Study of the 12 Month Effect of Treatment With Once Daily Triamcinolone Acetonide (NASACORT® AQ Nasal Spray 110 μg) on the Growth Velocity of Children, 3 to 9 Years of Age, With Perennial Allergic Rhinitis (PAR)
- ClinicalTrials.gov ID
- NCT00449072
- Acronym / sponsor ID
- XRG5029C_3503
- Conditions
- Rhinitis, Allergic, Perennial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Posted 7 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo (NASACORT® AQ placebo group) for 12-months.
The secondary objectives were to compare the following in prepubertal participants treated with TAA nasal spray versus placebo:
- the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure the Hypothalamic-Pituitary Adrenal [HPA] axis function)
- the rate of treatment-emergent-adverse-events (TEAE)
- global efficacy rated by the investigator and the participant separately
- the rate of use of rescue medication during the study
Detailed description
The study consisted of:
- a 4- to 6-month screening/baseline period
- a 12-month (up to Day 360+/-5 days) double-blind treatment period starting on Day 1
- a 2-month follow-up period (up to Day 420+/-5 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo, Drug: Claritin®3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered * Placebo in the baseline/screening period to demonstrate administration of investigational product (IP) with the nasal spray bottle * Placebo in the double-blind treatment period All participants were provided Children's Claritin® Syrup as a rescue medication. |
| TAA-AQ | Active comparator | Other: Placebo, Drug: TAA-AQ, Nasacort® AQ, Drug: Claritin®3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered * Placebo in the baseline/screening period to demonstrate administration of IP with the nasal spray bottle * Triamcinolone acetonide (TAA-AQ) in the double-blind treatment period All participants were provided Children's Claritin® Syrup as a rescue medication. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male participants [3 years to <= 9 years + 0 days old] at Visit 1 and no older than [9 years + 120 days] at Visit 3; and, female participants [3 years to <= 8 years + 0 days old] at Visit 1 and no older than [8 years + 120 days] at Visit 3: all sexually prepubertal (ie, Stage 1 of Tanner Classification of sexual maturity) at Visit 1 and Visit 3. A 5-day extension to the age upper bound was permitted under certain circumstances to enable scheduling of Visits 1 and 3
- At least a one year history of PAR as assessed and documented by the investigator (with or without seasonal allergic rhinitis [SAR])
- Positive skin test (prick or intradermal) to a perennial allergen that was present in the participant's environment. A skin test was considered positive if the wheal produced by the allergen was equal to or greater than that caused by positive control (histamine) or was at least 3 mm (prick test) or 7 mm (intradermal test) greater than the wheal of negative control (saline). If a skin test could not be performed, the radioallergosorbent test (RAST) would be used as an alternative. Documented historical skin testing or RAST performed during the past year were acceptable
- Height within the 3rd and 97th percentiles at screening (Visit 1), Visit 2, and at randomization (Visit 3)
- Symptomatic (daily AM instantaneous total nasal symptom score was >= 4 out of 12) on any 4 out of the last 7 consecutive days immediately prior to and including the morning of Visit 3. Symptom ratings were to be completed with the help of a parent/guardian/caregiver
Key exclusion criteria (18 listed)
- Gross nasal anatomical deformities including large polyposis and marked deviated septum
- History of or current cataract or glaucoma
- History of hypersensitivity to the corticosteroids or to any excipient of the investigational product
- Participant was the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- Height, weight, or body mass index (BMI)-for-age below the 3rd or above the 97th percentile at Visits 1, 2, or 3
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 |
|---|---|---|
| PlaceboPlacebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration | Other | Placebo, TAA-AQ |
| PlaceboPlacebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period | Other | Placebo |
| TAA-AQ, Nasacort® AQ110 μg TAA-AQ was administered once daily intranasally (1 spray delivering 55 μg of TAA-AQ in each nostril) during the double-blind treatment period | Drug | TAA-AQ |
| Claritin®Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used throughout the study on an as needed basis according to the Food and Drug Administration-approved manufacturer's label | Drug | Placebo, TAA-AQ |
Primary outcome
Growth Velocity
Time frame: Day 1 to end of treatment (Day 360)
Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time. Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing.
9 secondary outcomes
Change From Baseline in Instantaneous Total Nasal Symptom Score (TNSS)
Time frame: For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)
Change From Baseline in Four Individual Nasal Symptom Scores at the End of Treatment
Time frame: For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)
Global Efficacy as Assessed by the Participant (With the Help of a Parent/Guardian/Caregiver) During and at the End of the Double-blind Treatment Period
Time frame: Day 120, Day 240 and Day 360
Global Efficacy as Assessed by the Investigator During and at the End of the Double-blind Treatment Period
Time frame: Day 120, Day 240 and Day 360
Percentage of Participants Who Used the Rescue Medication During the Double-blind Phase of the Study
Time frame: Baseline (4-6 months before Day 1), double-blind treatment period (Day 1 to Day 360) and follow-up (Day 361 to Day 420)
Percentage of Days Participants Used the Rescue Medication During the Double-blind Treatment Phase of the Study
Time frame: double-blind treatment period (Day 1 to Day 360)
24 Hour Urinary Free Cortisol Levels
Time frame: Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)
24 Hour Cortisol/Creatinine Ratio
Time frame: Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420)
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Time frame: From Day 1 to 7 days following end of treatment (Day 360)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Akbar Akbary, MD study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TAA-AQ, Nasacort® AQ and Claritin® in people with Rhinitis, Allergic, Perennial, run by Sanofi at 1 site 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 7 inclusion and 18 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 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 7 Aug 2012). 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?
Growth Velocity (time frame: Day 1 to end of treatment (Day 360)). 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 10 Aug 2012.