WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Dermatitis, Atopic

Treatments

Drug: WAL 801 CL Dry Syrup

Drug: Ketotifen Fumarate Dry Syrup

Drug: WAL 801 CL Dry Syrup placebo

Drug: Ketotifen Fumarate Dry Syrup placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02182557

262.259

Details and patient eligibility

About

Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and to confirm the appropriateness of dosage of WAL801 Dry Syrup.

Enrollment

162 patients

Sex

All

Ages

Under 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

For inclusion in this study, patients must be pediatric atopic dermatitis patients that meet the following criteria and thus be appropriate for observation of pruritus. Diagnosis of atopic dermatitis was conducted in accordance with the "Definition and Diagnostic Criteria of Atopic Dermatitis" issued by the Japanese Dermatological Association.

15 years of age or younger
Body weight of 14 kg or more
Outpatients
One week or longer has passed since the patient started to use an external steroid preparation at "Strong" or lower grade, or stopped using any external steroid preparation, at the time of obtainment of consent from the patient
Pruritus with "2" or higher grade, immediately before initial administration

Exclusion criteria

Use of sustained release adrenocorticotropic hormone (Kenacort® A, Depo-medrol®, etc.), oral preparation of methotrexate, or oral preparation of ciclosporin, within 4 weeks before initial administration of the investigational product
Oral intake, inhalation and injection of any steroid within 2 weeks before initial administration of the investigational product
Use of any external steroid preparation at "Very Strong" or higher grade in any sites other than the face or scalp within 2 weeks before initial administration of the investigational product
Undergoing phototherapy
Undergoing specific desensitization therapy or modulation therapy
Past history of contact dermatitis caused by external steroid preparation
Possibility of exacerbation by an external steroid preparation of infectious skin disease caused by bacteria, fungi, or virus
Present and past history of convulsive disorder, such as epilepsy (convulsion threshold values may be lowered by the reference drug, Ketotifen Fumarate)
Clinically significant hepatic, renal, or cardiac disease or other complications: therefore, judgement that the patient is ineligible for inclusion in this study (Please note that patients must be excluded from the study if the patients fell under Grade 2 or more, in the MHW (Ministry of health and welfare) Adverse Reaction Severity Classification Criteria.)
Past history of allergy to any drug
Participation in any other clinical study, or history of participation in any other clinical study within 6 months before the date when the patient gave consent to participate in this study
Judgement by the Principal Investigator or Investigator that the patient is ineligible for inclusion in this study