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NCT01915823 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)
A Phase 3 study, sponsored by Meda Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 348
- Enrollment target
NCT01915823: Completed Phase 3 study, sponsored by Meda Pharmaceuticals.
NCT01915823 is a Phase 3 study that has completed, run by Meda Pharmaceuticals. The registered enrollment target is 348 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01915823, a Phase 3 study, has completed, sponsored by Meda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 348 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to \<12 years old who have seasonal allergic rhinitis.
Primary Outcome
change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negati
Interventions
- DRUG azelastine hydrochloride and fluticasone propionate
- DRUG Dymista vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2013-07 |
| Phase | Phase 3 |
What the finished NCT01915823 record still lists
NCT01915823 is an interventional study that assigns participants to a tested intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which azelastine hydrochloride and fluticasone propionate is the first listed.
NCT01915823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01915823 about?
NCT01915823 is a clinical study titled "Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)". The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to \<12 years old who have seasonal allergic rhinitis.
What is the current status of trial NCT01915823?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 348 participants. The study started on 2013-07.
What interventions are being tested in trial NCT01915823?
The interventions under investigation include: azelastine hydrochloride and fluticasone propionate (DRUG), Dymista vehicle (DRUG).
Who is sponsoring clinical trial NCT01915823?
This trial is sponsored by Meda Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01915823's enrollment target sits among peer trials
348 1045th of 2000 higher than 953 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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