A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 2 Weeks in Pediatric Subjects Ages 2 to <12 Years With Seasonal Allergic Rhinitis (SAR)

GlaxoSmithKline1 site in 1 country576 target enrollmentMarch 2005

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rhinitis, Allergic, Perennial
Sponsor: GlaxoSmithKline
Enrollment: 576
Locations: 1
Primary Endpoint: Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years.
Status: Completed
Last Updated: 9 years ago

The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

November 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years.

Improvement in AM, pre-dose, instantaneous total nasal symptom scores after 2 weeks of treatment, overall evaluation of response to therapy after 2 weeks of treatment for subjects ages 6 to <12 years.