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Completed

NCT Number: NCT02182570

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WAL 801 CL Dry Syrup

Drug

Primary outcomes

  1. Overall incidence of adverse events

    Time frame: up to 12 weeks

  2. Occurrence of abnormal changes in laboratory measurements (haematological tests, blood biochemical tests, and urinalysis)

    Time frame: Baseline, weeks 4, 8 and 12

Secondary outcomes

  1. Degree of pruritus

    Time frame: at weeks 4, 8 and 12

  2. Degree of rash

    Time frame: at weeks 4, 8 and 12

  3. Pruritus score obtained through the itching questionnaire

    Time frame: at weeks 4, 8 and 12

  4. Impression on pruritus of the patient or the parent

    Time frame: week 12

  5. Plasma concentration of epinastine hydrochloride

    Time frame: pre-dose and 6, 12, 18, 24, 30, 36 hours post-dose

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2002
First posted
Jul 8, 2014
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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