Safety Study To Assess Growth In Children With Seasonal Allergic And/Or Perennial Allergic Rhinitis Treated With GW685698X Aqueous Nasal Spray Or Placebo Nasal Spray

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Perennial and Seasonal
• Interventions: Drug: GW685698X

• Registration Number: NCT00109486
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to assess any effect in children with seasonal and/or perennial allergic rhinitis by GW685698X aqueous nasal spray (versus vehicle placebo nasal spray) on growth using knemometry.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-04-28
• Study First Submitted QC: 2005-04-28
• Study First Posted: 2005-04-29
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	GW685698X	-

Primary Outcome Measures

Name	Time	Method
The primary safety endpoint will be the mean growth velocity (mm/wk) in lower leg growth, as determined by knemometry, over a 2-week treatment period with intranasal GW685698X aqueous nasal spray versus a 2-week treatment with placebo nasal spray.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints will include the frequency and type of clinical adverse events (AEs) experienced during treatment, nasal examinations, vital signs (systolic and diastolic blood pressure, heart rate [pulse]).

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇰 Randers, Denmark