WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: WAL 801 CL dry syrup

• Study Type: Interventional
• Enrollment (Actual): 62
• 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, 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WAL 801 CL	Drug: WAL 801 CL dry syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

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): February 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; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Epinastine
• Other Study ID Numbers: 262.260