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NCT02709538 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
A Phase 3 study of Perennial Allergic Rhinitis, sponsored by Glenmark Specialty S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 601
- Enrollment target
- 20
- Study locations
NCT02709538: Completed Phase 3 study of Perennial Allergic Rhinitis, sponsored by Glenmark Specialty S.A..
NCT02709538 is a Phase 3 study of Perennial Allergic Rhinitis that has completed, run by Glenmark Specialty S.A.. The registered enrollment target is 601 participants, above the 461-participant average among 4 other Perennial Allergic Rhinitis trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02709538, a Phase 3 study of Perennial Allergic Rhinitis, has completed, sponsored by Glenmark Specialty S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 601 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)
Primary Outcome
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
Conditions Studied
Interventions
- DRUG GSP 301 NS
- DRUG GSP 301 Placebo NS pH 3.7
- DRUG GSP 301 Placebo NS pH 7.0
Study Locations (20)
California
- Investigational Site 28 - Encinitas
- Investigational Site 27 - San Diego
- Investigational Site 29 - San Diego
Florida
- Investigational Site 26 - Aventura
- Investigational Site 9 - Miami
- Investigational Site 33 - Tallahassee
North Carolina
- Investigational Site 7 - High Point
- Investigational Site 21 - Raleigh
Arkansas
- Investigational Site 2 - Hot Springs
Colorado
- Investigational Site 32 - Denver
Georgia
- Investigational Site 11 - Stockbridge
Kentucky
- Investigational Site 4 - Louisville
Maryland
- Investigational Site 5 - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 601 participants |
| Start Date | 2016-04 |
| Est. Completion | 2017-07 |
| Phase | Phase 3 |
What the finished NCT02709538 record still lists
NCT02709538 is an interventional study that assigns participants to a tested intervention. The registered 601 participants enrollment target is mid-sized for trials with a published cap, above the 461-participant average among 4 other Perennial Allergic Rhinitis trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Perennial Allergic Rhinitis appearing as the primary indexed condition, and to 3 interventions - of which GSP 301 NS is the first listed.
NCT02709538 names 20 study sites across 15 states, led by California, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02709538 about?
NCT02709538 is a clinical study titled "Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)". To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)
What is the current status of trial NCT02709538?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 601 participants. The study started on 2016-04. Estimated completion is 2017-07.
What conditions does trial NCT02709538 study?
This clinical trial studies the following conditions: Perennial Allergic Rhinitis.
What interventions are being tested in trial NCT02709538?
The interventions under investigation include: GSP 301 NS (DRUG), GSP 301 Placebo NS pH 3.7 (DRUG), GSP 301 Placebo NS pH 7.0 (DRUG).
Who is sponsoring clinical trial NCT02709538?
This trial is sponsored by Glenmark Specialty S.A., which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02709538 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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