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

Dermatitis Clinical Trial

Official title:
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)

Clinical Trial 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.

Clinical Trial Description

This is a randomized, double-blind, parallel-group comparative study to demonstrate the noninferiority of TAU-284 to ketotifen fumarate in pediatric patients with atopic dermatitis, as assessed by the primary endpoint of the change from baseline in pruritus score after 2-week treatment with TAU-284 (20 mg/day) or ketotifen fumarate dry syrup (2 g/day); and to investigate the safety, and plasma concentrations of TAU-284. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01840605
Study type Interventional
Source Mitsubishi Tanabe Pharma Corporation
Contact
Status Completed
Phase Phase 3
Start date March 2013
Completion date November 2013
View Details
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