NCT03463031

Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Glenmark Specialty S.A. · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Conditions

• Seasonal Allergic Rhinitis (SAR)

Interventions

Type	Name	Description
DRUG	GSP 301 NS	1 spray in each nostril twice daily for 14 days
DRUG	GSP 301 Placebo NS	1 spray in each nostril twice daily for 14 days

Timeline

• Start date: 2018-03-16
• Primary completion: 2018-11-14
• Completion: 2018-11-14
• First posted: 2018-03-13
• Last updated: 2019-10-08
• Results posted: 2019-10-08

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study