At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 473 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 Perennial Allergic Rhinitis (A Randomized, Double-blind, Placebo-controlled Study)
In Brief
A Phase 3 clinical trial evaluating Bepotastine besilate and Placebo for Perennial Allergic Rhinitis. Completed, enrolled 473 participants across 2 sites.
Detailed Summary
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerennial Allergic Rhinitis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2013
First PostedMay 2013
Primary CompletionDec 2013
TodayJul 2026
First PostedMay 23, 2013
Enrollment StartApr 1, 2013
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.1 years ago
Interventions
Bepotastine besilatedrug
Two TAU-284 5mg tablets will be taken orally twice a day
Placebodrug
Two Placebo tablets will be taken orally twice a day