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

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Bepotastine besilate
ketotifen fumarate
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Corporation Kojinkai Asanuma Dermatology Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAU-284

ketotifen fumarate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Pruritus Score
The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).

Secondary Outcome Measures

Change From Baseline in Pruritus Score
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)
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)
Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).

Full Information

First Posted
April 23, 2013
Last Updated
September 28, 2017
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01840605
Brief Title
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
Official Title
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAU-284
Arm Type
Experimental
Arm Description
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.
Arm Title
ketotifen fumarate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bepotastine besilate
Other Intervention Name(s)
TALION 5mg tablets
Intervention Description
Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day
Intervention Type
Drug
Intervention Name(s)
ketotifen fumarate
Other Intervention Name(s)
ketotifen fumarate dry syrup
Intervention Description
Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day
Primary Outcome Measure Information:
Title
Change From Baseline in Pruritus Score
Description
The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Time Frame
Baseline and 2 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Pruritus Score
Description
The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Time Frame
Baseline and 1 weeks
Title
Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)
Description
Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).
Time Frame
Baseline and 2 weeks
Title
Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)
Description
Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).
Time Frame
Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MAKOTO KAWASHIMA
Organizational Affiliation
Tokyo Women's Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Medical Corporation Kojinkai Asanuma Dermatology Clinic
City
Hokkaido
Country
Japan

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result

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

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