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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2013

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: TAU-284
    • Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day, once after breakfast and once before bed.
  • Active Comparator: ketotifen fumarate
    • Two TAU-284 5mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day, once after breakfast and once before bed.

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Pruritus Score
    • Time Frame: Baseline and 2 weeks
    • The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mitsubishi Tanabe Pharma Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • MAKOTO KAWASHIMA, Study Director, Tokyo Women’s Medical University

Citations Reporting on 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

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