drugset / Trial / NCT03463031

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

NCT03463031

Phase 3 Completed 446 enrolled Glenmark Specialty S.A.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2018-03-16
Primary completion
2018-11-14
Completion
2018-11-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Mometasone Other / unclassified 25 ug Intranasal
Subject Olopatadine Other / unclassified 665 ug Intranasal