Trials / Completed
CompletedNCT02709538
Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 601 (actual)
- Sponsor
- Glenmark Specialty S.A. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSP 301 NS | FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks |
| DRUG | GSP 301 Placebo NS pH 3.7 | 2 spray in each nostril twice daily for 52 weeks |
| DRUG | GSP 301 Placebo NS pH 7.0 | 2 spray in each nostril twice daily for 52 weeks |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2017-07-01
- Completion
- 2017-07-01
- First posted
- 2016-03-16
- Last updated
- 2020-02-26
- Results posted
- 2018-09-13
Locations
34 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02709538. Inclusion in this directory is not an endorsement.