At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,176 enrolled
Drug / intervention
GSP 301 NS +3 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 Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)
In Brief
A Phase 3 clinical trial evaluating GSP 301 NS, GOM-NS, and 2 other interventions for Seasonal Allergic Rhinitis (SAR). Completed, enrolled 1,176 participants across 43 sites.
Detailed Summary
Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis (SAR)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
First PostedAug 2016
Primary CompletionJan 2017
TodayJul 2026
First PostedAug 17, 2016
Enrollment StartAug 1, 2016
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 9.9 years ago
Interventions
GSP 301 NSdrug
2 spray in each nostril twice daily for 14 days
GOM-NSdrug
2 spray in each nostril twice daily for 14 days
GMM-2 NSdrug
2 spray in each nostril twice daily for 14 days
GSP 301 placebo NSdrug
2 spray in each nostril twice daily for 14 days