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NCT02246920 · ClinicalTrials.gov registry record · Phase 3
Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
A Phase 3 study, sponsored by Teva Pharmaceuticals USA.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,474
- Enrollment target
NCT02246920: Clinical Trial Phase 3 study, sponsored by Teva Pharmaceuticals USA.
NCT02246920 is a Phase 3 study that was terminated before completion, run by Teva Pharmaceuticals USA. The registered enrollment target is 1,474 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02246920, a Phase 3 study, was terminated before completion, sponsored by Teva Pharmaceuticals USA.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,474 participants
- Enrollment target
Study Summary
This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone propionate) 50 mcg nasal spray (GlaxoSmithKline), in the relief of the signs and symptoms of Seasonal Allergic Rhinitis. Additionally, both the test and reference formulations will be tested for superiority against a placebo nasal spray.
Primary Outcome
Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated nasal symptom severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The higher the score, the worse the symptoms of the 4 allergy categories are (runny nose, nasal congestions, itchy nose, and sneezing. The primary analysis for determining the
Interventions
- DRUG Placebo
- DRUG Fluticasone propionate
- DRUG Flonase®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,474 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2014-07-14 |
| Phase | Phase 3 |
Why NCT02246920 stopped before completion
NCT02246920 is an interventional study that assigns participants to a tested intervention. Its 1,474 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02246920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02246920 about?
NCT02246920 is a clinical study titled "Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients". This double-blind, randomized, placebo-controlled, parallel group, multi-site study has been designed to compare the safety and efficacy of a generic Fluticasone propionate Nasal Spray, 50 mcg (Teva Pharmaceuticals USA) to the FDA Reference Listed Drug, Flonase® (fluticasone propionate) 50 mcg nasal...
What is the current status of trial NCT02246920?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,474 participants. The study started on 2014-03-01. Estimated completion is 2014-07-14.
What interventions are being tested in trial NCT02246920?
The interventions under investigation include: Placebo (DRUG), Fluticasone propionate (DRUG), Flonase® (DRUG).
Who is sponsoring clinical trial NCT02246920?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02246920's enrollment target sits among peer trials
1,474 163rd of 2000 higher than 1,838 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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