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NCT00449072 · ClinicalTrials.gov registry record · Phase 4
Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 299
- Enrollment target
NCT00449072 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 299 participants.
The verdict
NCT00449072, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 299 participants
- Enrollment target
Study 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 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
Interventions
- OTHER Placebo
- DRUG TAA-AQ, Nasacort® AQ
- DRUG Claritin®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2007-03 |
| Est. Completion | 2011-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00449072
The ClinicalTrials.gov registry entry for NCT00449072 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 299 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00449072 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00449072 about?
NCT00449072 is a clinical study titled "Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, 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 g...
What is the current status of trial NCT00449072?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 299 participants. The study started on 2007-03. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00449072?
The interventions under investigation include: Placebo (OTHER), TAA-AQ, Nasacort® AQ (DRUG), Claritin® (DRUG).
Who is sponsoring clinical trial NCT00449072?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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