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WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182570
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: WAL 801 CL dry syrup Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Open-labeled Study of WAL 801 CL Dry Syrup in Pediatric Atopic Dermatitis Patients
Study Start Date : June 2001
Actual Primary Completion Date : February 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: WAL 801 CL Drug: WAL 801 CL dry syrup



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182570    
Other Study ID Numbers: 262.260
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinastine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs