At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 446 enrolled
Drug / intervention
GSP 301 NS +1 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 the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
In Brief
A Phase 3 clinical trial evaluating GSP 301 NS and GSP 301 Placebo NS for Seasonal Allergic Rhinitis (SAR). Completed, enrolled 446 participants across 32 sites.
Detailed Summary
Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis (SAR)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartMar 2018
Primary CompletionNov 2018
TodayJul 2026
First PostedMar 13, 2018
Enrollment StartMar 16, 2018
Primary CompletionNov 14, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.3 years ago
Interventions
GSP 301 NSdrug
1 spray in each nostril twice daily for 14 days
GSP 301 Placebo NSdrug
1 spray in each nostril twice daily for 14 days