Status:
COMPLETED
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rhinitis, Allergic, Perennial and Seasonal
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
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 kne...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Females (ages 6 to 11) who have not begun menses.
- Males (ages 6 to 12).
- Tanner Stage 1.
- History of SAR (Seasonal Allergic Rhinitis) or PAR (Perennial Allergic Rhinitis) of at least one year with either a current level of allergic rhinitis symptoms that warrants treatment and/or expected symptoms during a majority of the study period.
- Positive skin test to an appropriate seasonal or perennial allergen.
- Exclusion criteria:
- History of abnormal growth or gross malnutrition.
- Clinically significant laboratory abnormality.
- History of any condition that may have substantially affected growth.
- Historical or current evidence of clinically significant, uncontrolled disease of any body system.
- Any asthma other than mild, intermittent asthma controlled by short-acting, beta-agonists.
- Recent major surgery and/or trauma to the legs.
- History of adrenal insufficiency.
- Current or prior treatment with any medication that may have a potential for an ongoing effect on linear growth.
- Use of corticosteroids, by any route, within 4 weeks prior to Visit 1.
- Any nasal condition or deformity that would impair nasal breathing or deposition of medication.
- Physical impairment that would affect the subject's ability to participate in the study.
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00109486
Start Date
April 1 2005
End Date
November 1 2005
Last Update
September 15 2016
Active Locations (1)
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1
GSK Investigational Site
Randers, Denmark, 8900