WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

Last updated: July 11, 2014
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

3

Condition

Dermatitis, Atopic

Allergy

Eczema (Atopic Dermatitis - Pediatric)

Treatment

N/A

Clinical Study ID

NCT02182570
262.260
  • Ages < 15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: For inclusion in this study, subjects must be pediatric atopic dermatitis patients thatmeet the following criteria and thus be appropriate for observation of pruritus. Diagnosisof atopic dermatitis will be conducted in accordance with the "Definition and DiagnosticCriteria 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 externalsteroid preparation for >= 1 week at the time informed consent is obtained

  • Pruritus with "2" or higher grade at the start time of administration

Exclusion

Exclusion Criteria:

  • Use of sustained release adrenocorticotropic hormone (Kenacort® A, Depo-medrol®,etc.), oral preparation of methotrexate, or oral preparation of ciclosporin, within 4weeks before initial administration of the investigational product

  • Oral intake, inhalation and injection of any steroid within 2 weeks before initialadministration of the investigational product

  • Use of any external steroid preparation at "Strongest" in any sites other than theface or scalp within 2 weeks before initial administration of the investigationalproduct

  • 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 skindisease 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 ClassificationCriteria

  • Past history of allergy to any drug

  • Participation in any other clinical study, or history of participation in any otherclinical study within 6 months before the date when the patient gave consent toparticipate in this study

  • Judgement by the Principal Investigator or Investigator that the patient is ineligiblefor inclusion in this study

Study Design

Total Participants: 62
Study Start date:
June 01, 2001
Estimated Completion Date: