NCT02870205

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

A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,176 (actual)
• Sponsor: Glenmark Specialty S.A. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)

Conditions

• Seasonal Allergic Rhinitis (SAR)

Interventions

Type	Name	Description
DRUG	GSP 301 NS	2 spray in each nostril twice daily for 14 days
DRUG	GOM-NS	2 spray in each nostril twice daily for 14 days
DRUG	GMM-2 NS	2 spray in each nostril twice daily for 14 days
DRUG	GSP 301 placebo NS	2 spray in each nostril twice daily for 14 days

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-08-17
• Last updated: 2018-04-06
• Results posted: 2018-04-06

Locations

43 sites across 1 country: United States