NCT02318303

To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,111 (actual)
• Sponsor: Glenmark Pharmaceuticals Ltd. India · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	GSP 301-1 NS (QD)	GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
DRUG	GSP 301-2 NS (BID)	GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
DRUG	GSP 301 Placebo NS	GSP 301 placebo NS administered as 2 sprays/nostril
DRUG	Olopatadine HCl-1 NS (QD)	Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
DRUG	Olopatadine HCl-2 NS (BID)	Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
DRUG	Mometasone Furoate-1 NS (QD)	Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril
DRUG	Mometasone Furoate-2 NS (BID)	Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-12-17
• Last updated: 2020-10-20
• Results posted: 2017-06-28

Locations

10 sites across 1 country: United States