NCT02631551

Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,180 (actual)
• Sponsor: Glenmark Specialty S.A. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	GSP 301 NS	FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days
DRUG	Olopatadine HCl NS	2 sprays in each nostril twice daily for 14 days
DRUG	Mometasone furoate NS	2 sprays in each nostril twice daily for 14 days
DRUG	GSP 301 Placebo NS	2 sprays in each nostril twice daily for 14 days

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-12-16
• Last updated: 2018-09-25
• Results posted: 2018-08-15

Locations

37 sites across 1 country: United States