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

NCT ID: NCT01840605

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-11-30

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.

Conditions

Dermatitis; Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bepotastine besilate

Intervention Type: DRUG

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 5mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day, once after breakfast and once before bed.

Group Type: ACTIVE_COMPARATOR

ketotifen fumarate

Intervention Type: DRUG

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

Interventions

Bepotastine besilate

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

Intervention Type: DRUG

ketotifen fumarate

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

Intervention Type: DRUG

Other Intervention Names

TALION 5mg tablets; ketotifen fumarate dry syrup

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MAKOTO KAWASHIMA

Role: STUDY_DIRECTOR

Tokyo Women's Medical University

Locations

Medical Corporation Kojinkai Asanuma Dermatology Clinic

Hokkaido, , Japan

Countries

Japan

References

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

Reference Type: RESULT

Other Identifiers

TAU-284-19

Identifier Type: -

Identifier Source: org_study_id