NCT01840605

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Dermatitis
• Atopic

Interventions

Type	Name	Description
DRUG	Bepotastine besilate	Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day
DRUG	ketotifen fumarate	Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-04-26
• Last updated: 2026-01-08
• Results posted: 2015-10-16

Locations

1 site across 1 country: Japan