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NCT00132925
An Efficacy and Safety Evaluation of Nasacort AQ 110 µg QD Children Ages 2-5 Years With Perennial Allergic Rhinitis
Phase 3 trial testing Triamcinolone in Rhinitis, Allergic, Perennial in 460 participants. Completed in 1 February 2006.
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 460 |
| Start date | 1 November 2003 |
| Estimated completion | 1 February 2006 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Triamcinolone (TRIAMCINOLONE) — full drug profile →
Conditions studied
- Rhinitis, Allergic, Perennial — all drugs for Rhinitis, Allergic, Perennial →
Sponsor
Sanofi — full company profile →
Who can join
Adults 2 to 5, any sex, with Rhinitis, Allergic, Perennial. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Double-blind phase: Change from baseline in mean daily instantaneous (immediately prior to dosing) Total Nasal Symptom Score (TNSS) over the 4-week double-blind period
- Open-label phase: The efficacy variable is the global evaluation of efficacy as rated by the physician and the subject
Sponsor's own description
The purposes of this study are: * To demonstrate the efficacy of once daily administration of Nasacort AQ 110 µg compared with placebo in children 2-5 years of age with perennial allergic rhinitis; and * To assess the safety of Nasacort AQ 110 µg in children 2-5 years of age.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00132925
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00132925 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 10 January 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00132925.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing