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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Bepotastine besilate; Ketotifen

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