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

September 28, 2017 updated by: Mitsubishi Tanabe Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hokkaido, Japan
        • Medical Corporation Kojinkai Asanuma Dermatology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Bepotastine besilate
Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day
Other Names:
  • TALION 5mg tablets
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.
Drug: ketotifen fumarate
Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day
Other Names:
  • ketotifen fumarate dry syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 1 weeks
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).
Baseline and 2 weeks
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).
Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Study Director: MAKOTO KAWASHIMA, Tokyo Women's Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAU-284-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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