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drugset / Trial / NCT01840605

A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis

NCT01840605 ↗

Phase 3 Completed 303 enrolled Tanabe Pharma Corporation
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-03
Primary completion
2013-11
Completion
2013-11

Publications

  • Results Kawashima M; Ichimura M; Yano K; Susuta Y; Izaki H. Phase III study of bepotastine besilate in children with atopic dermatitis -A randomized, double-blind, parallel-group, comparative study with ketotifen fumarate dry syrup- Rinsho iyaku 2015 Mar;31(3):235-251

Drugs

EvaluationDrugModalityDoseRoute
Subject Bepotastine Small molecule 10 mg Oral
Comparator Ketotifen Small molecule 1 g Oral

Indications

atopic eczema