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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00108914 |
The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.
Condition | Intervention | Phase |
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Perennial Allergic Rhinitis |
Drug: GW685698X |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 576 |
Study Start Date: | February 2005 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to <12 Years with Perennial Allergic Rhinitis (PAR)
Ages Eligible for Study: | 2 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | FFR30008 |
Study First Received: | April 20, 2005 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00108914 |
Health Authority: | United States: Food and Drug Administration; Mexico: National Institute of Public Health, Health Secretariat; Slovakia: State Institute for Drug Control; Finland: National Agency for Medicines; Italy: Ministry of Health; United States: Food and Drug Administration |
Perennial allergic rhinitis pediatric |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Rhinitis, Allergic, Perennial Hypersensitivity, Immediate Rhinitis Respiratory Hypersensitivity |
Immune System Diseases Nose Diseases |