Skip to main content
Clinical Trials/NCT00116883
NCT00116883
Completed
Phase 3

A Randomized, Double-blind, Parallel Group, Placebo Controlled, 6-week Study of the Effect of GW685698X Aqueous Nasal Spray 100mcg QD on the Hypothalamic Pituitary Adrenocortical (HPA) Axis in Children 2 to 11 Years of Age With Perennial Allergic Rhinitis (PAR).

GlaxoSmithKline1 site in 1 country90 target enrollmentFebruary 2005

Overview

Phase
Phase 3
Intervention
GW685698X aqueous nasal spray
Conditions
Rhinitis, Allergic, Perennial
Sponsor
GlaxoSmithKline
Enrollment
90
Locations
1
Primary Endpoint
HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in children 2 to 11 years of age with perennial allergic rhinitis.

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
July 2005
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Arm 1

Intervention: GW685698X aqueous nasal spray

Outcomes

Primary Outcomes

HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects

Secondary Outcomes

  • Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.

Study Sites (1)

Loading locations...

Similar Trials