WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients

Phase III Double-Blind Comparative Study of WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: WAL 801 CL Dry Syrup; Drug: Ketotifen Fumarate Dry Syrup placebo; Drug: Ketotifen Fumarate Dry Syrup; Drug: WAL 801 CL Dry Syrup placebo

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WAL 801 CL Dry Syrup + Placebo	Drug: WAL 801 CL Dry Syrup; Drug: Ketotifen Fumarate Dry Syrup placebo
Active Comparator: Ketotifen Fumarate Dry Syrup + Placebo	Drug: Ketotifen Fumarate Dry Syrup; Drug: WAL 801 CL Dry Syrup placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Degree of pruritus	at week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Degree of pruritus	at week 2
Degree of rash	at weeks 2 and 4
Pruritus score obtained through the itching questionnaire	at weeks 2 and 4
Impression on pruritus of the patient or the parent	at week 4
Occurrence of adverse events	up to 4 weeks
Number of patients with abnormal changes from baseline in laboratory measurements (hematological tests, blood biochemical tests, and urinalysis)	Baseline and week 4

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): January 1, 2002

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Epinastine; Ketotifen
• Other Study ID Numbers: 262.259