A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
Phase 3
Completed
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Drug: GW685698X aqueous nasal spray
- Registration Number
- NCT00116883
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 GW685698X aqueous nasal spray -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Richmond, Virginia, United States
GSK Investigational Site🇺🇸Richmond, Virginia, United States