At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 303 enrolled
Drug / intervention
Bepotastine besilate +1 moredrug
Likely dose
Bepotastine besilate 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)
In Brief
A Phase 3 clinical trial evaluating Bepotastine besilate and ketotifen fumarate for Dermatitis and Atopic. Completed, enrolled 303 participants across 1 site.
Detailed Summary
The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Atopic
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2013
First PostedApr 2013
Primary CompletionNov 2013
TodayJul 2026
First PostedApr 26, 2013
Enrollment StartMar 1, 2013
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.2 years ago
Interventions
Bepotastine besilatedrug
Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day
ketotifen fumaratedrug
Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day