WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02182570
• Other study ID #: 262.260
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2014
• Last updated: July 11, 2014
• Start date: June 2001

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• WAL 801 CL dry syrup

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall incidence of adverse events		up to 12 weeks	No
Primary	Occurrence of abnormal changes in laboratory measurements (haematological tests, blood biochemical tests, and urinalysis)		Baseline, weeks 4, 8 and 12	No
Secondary	Degree of pruritus		at weeks 4, 8 and 12	No
Secondary	Degree of rash		at weeks 4, 8 and 12	No
Secondary	Pruritus score obtained through the itching questionnaire		at weeks 4, 8 and 12	No
Secondary	Impression on pruritus of the patient or the parent		week 12	No
Secondary	Plasma concentration of epinastine hydrochloride		pre-dose and 6, 12, 18, 24, 30, 36 hours post-dose	No

External Links

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