A Phase 3 interventional study of GW685698X in Rhinitis, Allergic, Perennial, sponsored by GlaxoSmithKline. Completed at 66 sites in 7 countries. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2017-01-19.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.
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)
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 558 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years.
Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline