At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 601 enrolled
Drug / intervention
GSP 301 NS +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating GSP 301 NS, GSP 301 Placebo NS pH 3.7, and 1 other intervention for Perennial Allergic Rhinitis. Completed, enrolled 601 participants across 34 sites.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerennial Allergic Rhinitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionJul 2017
TodayJul 2026
First PostedMar 16, 2016
Enrollment StartApr 1, 2016
Primary CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.3 years ago
Interventions
GSP 301 NSdrug
FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks
GSP 301 Placebo NS pH 3.7drug
2 spray in each nostril twice daily for 52 weeks
GSP 301 Placebo NS pH 7.0drug
2 spray in each nostril twice daily for 52 weeks