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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Dermatitis; Atopic

Treatments: Drug: Bepotastine besilate; Drug: ketotifen fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01840605

TAU-284-19

Details and patient eligibility

About

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 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.

Enrollment: 303 patients

Sex: All

Ages: 7 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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303 participants in 2 patient groups

TAU-284

Experimental group

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.

Treatment:

Drug: Bepotastine besilate

ketotifen fumarate

Active Comparator group

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.

Treatment:

Drug: ketotifen fumarate