Dermatitis Clinical Trial
Official title:
A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis (Ketotifen Fumarate-controlled, Double-blind, Comparative Study)
NCT number | NCT01840605 |
Other study ID # | TAU-284-19 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 2013 |
Est. completion date | November 2013 |
Verified date | September 2017 |
Source | Mitsubishi Tanabe Pharma Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 303 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 15 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Medical Corporation Kojinkai Asanuma Dermatology Clinic | Hokkaido |
Lead Sponsor | Collaborator |
---|---|
Mitsubishi Tanabe Pharma Corporation |
Japan,
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):23
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Pruritus Score | The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe). | Baseline and 2 weeks | |
Secondary | Change From Baseline in Pruritus Score | The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe). | Baseline and 1 weeks | |
Secondary | 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). | Baseline and 2 weeks | |
Secondary | 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). | Week 2 |
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