CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,180 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.

Search/NCT02631551
NCT02631551Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

Glenmark Specialty S.A.·interventional·Posted Dec 16, 2015·Updated Sep 25, 2018

In Brief

A Phase 3 clinical trial evaluating GSP 301 NS, Olopatadine HCl NS, and 2 other interventions for Seasonal Allergic Rhinitis. Completed, enrolled 1,180 participants across 37 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Allergic Rhinitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 16, 2015
Enrollment StartMar 1, 2016
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.5 years ago

Interventions

GSP 301 NSdrug

FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days

Olopatadine HCl NSdrug

2 sprays in each nostril twice daily for 14 days

Mometasone furoate NSdrug

2 sprays in each nostril twice daily for 14 days

GSP 301 Placebo NSdrug

2 sprays in each nostril twice daily for 14 days