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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: Completed Phase 3 study of Seasonal Allergic Rhinitis, sponsored by Glenmark Specialty S.A..
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident
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 |
What the finished NCT02631551 record still lists
NCT02631551 is an interventional study that assigns participants to a tested intervention. Its 1,180 participants enrollment target places it among the larger protocols in the corpus, above the 594-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target (99% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Seasonal Allergic Rhinitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02631551's enrollment target sits among peer trials
1,180 2nd of 16 the highest of 16 other Seasonal Allergic Rhinitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Seasonal Allergic Rhinitis 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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