WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

Study Overview
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Brief Summary
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The safety and efficacy of WAL 801 CL (epinastine hydrochloride) Dry Syrup in the treatment of atopic dermatitis in children was evaluated and plasma drug concentrations were measured.

Official Title
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Phase III Open-labeled Study of WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: WAL 801 CL dry syrup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For inclusion in this study, subjects must be pediatric atopic dermatitis patients that meet the following criteria and thus be appropriate for observation of pruritus. Diagnosis of atopic dermatitis will be 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 The patient has been undergoing treatment with a very strong or lower-grade external steroid preparation for >= 1 week at the time informed consent is obtained Pruritus with 2 or higher grade at the start time of 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 Strongest 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 Clinically significant hepatic, renal, or cardiac disease or other complications: therefore, judgement that the patient was ineligible for inclusion in this study. 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

Ages Eligible for Study
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Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WAL 801 CL<br> | Drug: WAL 801 CL dry syrup<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall incidence of adverse events |  | up to 12 weeks | 
| Occurrence of abnormal changes in laboratory measurements (haematological tests, blood biochemical tests, and urinalysis) |  | Baseline, weeks 4, 8 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of pruritus |  | at weeks 4, 8 and 12 | 
| Degree of rash |  | at weeks 4, 8 and 12 | 
| Pruritus score obtained through the itching questionnaire |  | at weeks 4, 8 and 12 | 
| Impression on pruritus of the patient or the parent |  | week 12 | 
| Plasma concentration of epinastine hydrochloride |  | pre-dose and 6, 12, 18, 24, 30, 36 hours post-dose |