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NCT02125253 · ClinicalTrials.gov registry record · Phase 3
Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
A Phase 3 study, sponsored by Amneal Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 811
- Enrollment target
NCT02125253: Completed Phase 3 study, sponsored by Amneal Pharmaceuticals.
NCT02125253 is a Phase 3 study that has completed, run by Amneal Pharmaceuticals. The registered enrollment target is 811 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02125253, a Phase 3 study, has completed, sponsored by Amneal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 811 participants
- Enrollment target
Study Summary
To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis
Primary Outcome
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS) over Days 1 to 14
Interventions
- DRUG Placebo Nasal Spray
- DRUG Mometasone Furoate Nasal Spray, 50 mcg
- DRUG Nasonex Nasal Spray, 50 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 811 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT02125253 record still lists
NCT02125253 is an interventional study that assigns participants to a tested intervention. The registered 811 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo Nasal Spray is the first listed.
NCT02125253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02125253 about?
NCT02125253 is a clinical study titled "Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis". To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis
What is the current status of trial NCT02125253?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 811 participants. The study started on 2014-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT02125253?
The interventions under investigation include: Placebo Nasal Spray (DRUG), Mometasone Furoate Nasal Spray, 50 mcg (DRUG), Nasonex Nasal Spray, 50 mcg (DRUG).
Who is sponsoring clinical trial NCT02125253?
This trial is sponsored by Amneal Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02125253's enrollment target sits among peer trials
811 408th of 2000 higher than 1,592 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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