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 Details — Status: Completed

Administrative data

• NCT number: NCT01840605
• Other study ID #: TAU-284-19
• Status: Completed
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2017
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

Inclusion Criteria:

• Patients aged between 7 and 15 years

• Patients giving assent and whose legal guardian giving informed consent

• Outpatients

• Patients diagnosed as atopic dermatitis

• Patients who require the treatment with topical corticosteroid on areas other than face, head and neck

• Patients whose diaries can be properly maintained

• Patients who have 2 grades or more pruritus score

Exclusion Criteria:

• Patients with bronchial asthma who require concomitant use of the corticosteroid

• Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy

• Patients with current or previous history of drug hypersensitivity

• Patients who have been treated with Bepotastine besilate in the past

• Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied

• Patients who have spastic disease such as epilepsy

• Patients who concurrently have renal function abnormalities that may cause safety problems

• Patients who do not give consent to use birth control

• Pregnant patients, at risk of pregnancy or breastfeeding

• Patients who had participated in any clinical trial in the last 12 weeks

Related Conditions & MeSH terms

• Atopic
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Bepotastine besilate
Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day
• ketotifen fumarate
Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day

Locations

Country	Name	City	State
Japan	Medical Corporation Kojinkai Asanuma Dermatology Clinic	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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):23

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Pruritus Score	The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).	Baseline and 2 weeks
Secondary	Change From Baseline in Pruritus Score	The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).	Baseline and 1 weeks
Secondary	Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)	Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).	Baseline and 2 weeks
Secondary	Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)	Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).	Week 2