CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,111 enrolled
Drug / intervention
GSP 301-1 NS (QD) +6 moredrug
Likely dose
GSP 301-1 NS (QD) 665 μgfrom 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/NCT02318303
NCT02318303Phase 2Completed
CompareCT.gov

A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators), in Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR)

Glenmark Pharmaceuticals Ltd. India·interventional·Posted Dec 17, 2014·Updated Oct 20, 2020

In Brief

A Phase 2 clinical trial evaluating GSP 301-1 NS (QD), GSP 301-2 NS (BID), and 5 other interventions for Seasonal Allergic Rhinitis. Completed, enrolled 1,111 participants across 10 sites.

Detailed Summary

Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 17, 2014
Enrollment StartDec 1, 2014
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.5 years ago

Interventions

GSP 301-1 NS (QD)drug

GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril

GSP 301-2 NS (BID)drug

GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril

GSP 301 Placebo NSdrug

GSP 301 placebo NS administered as 2 sprays/nostril

Olopatadine HCl-1 NS (QD)drug

Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril

Olopatadine HCl-2 NS (BID)drug

Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril

Mometasone Furoate-1 NS (QD)drug

Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril

Mometasone Furoate-2 NS (BID)drug

Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril