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NCT02631551 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
A Phase 3 study of Seasonal Allergic Rhinitis, sponsored by Glenmark Specialty S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 1,180
- Enrollment target
- 20
- Study locations
NCT02631551 is a Phase 3 study of Seasonal Allergic Rhinitis that has completed, run by Glenmark Specialty S.A.. The registered enrollment target is 1,180 participants, above the 594-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (99% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT02631551, a Phase 3 study of Seasonal Allergic Rhinitis, has completed, sponsored by Glenmark Specialty S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,180 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment
Conditions Studied
Interventions
- DRUG GSP 301 NS
- DRUG Olopatadine HCl NS
- DRUG Mometasone furoate NS
- DRUG GSP 301 Placebo NS
Study Locations (20)
California
- Investigational Site 20 - Mission Viejo
- Investigational Site 31 - San Diego
- Investigational Site 29 - San Jose
Georgia
- Investigational Site 37 - Marietta
- Investigational Site 15 - Stockbridge
- Investigational Site 23 - Stockbridge
Colorado
- Investigational Site 25 - Centennial
- Investigational Site 22 - Colorado Springs
Florida
- Investigational Site 10 - Jupiter
- Investigational Site 30 - Miami
Maryland
- Investigational Site 14 - Baltimore
- Investigational Site 33 - Wheaton
Kentucky
- Investigational Site 11 - Louisville
Michigan
- Investigational Site 26 - Ypsilanti
Minnesota
- Investigational Site 19 - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,180 participants |
| Start Date | 2016-03 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02631551
The ClinicalTrials.gov registry entry for NCT02631551 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,180 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 594-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (99% higher). The listed sponsor is Glenmark Specialty S.A., which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Seasonal Allergic Rhinitis appearing as the primary indexed condition, and to 4 interventions - of which GSP 301 NS is the first listed.
NCT02631551 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Georgia, Colorado.
Frequently Asked Questions
What is clinical trial NCT02631551 about?
NCT02631551 is a clinical study titled "Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)". Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment
What is the current status of trial NCT02631551?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,180 participants. The study started on 2016-03. Estimated completion is 2016-07.
What conditions does trial NCT02631551 study?
This clinical trial studies the following conditions: Seasonal Allergic Rhinitis.
What interventions are being tested in trial NCT02631551?
The interventions under investigation include: GSP 301 NS (DRUG), Olopatadine HCl NS (DRUG), Mometasone furoate NS (DRUG), GSP 301 Placebo NS (DRUG).
Who is sponsoring clinical trial NCT02631551?
This trial is sponsored by Glenmark Specialty S.A., which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02631551 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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