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WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients

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ClinicalTrials.gov Identifier: NCT02182557
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and to confirm the appropriateness of dosage of WAL801 Dry Syrup.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: WAL 801 CL Dry Syrup Drug: Ketotifen Fumarate Dry Syrup Drug: WAL 801 CL Dry Syrup placebo Drug: Ketotifen Fumarate Dry Syrup placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase III Double-Blind Comparative Study of WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients
Study Start Date : June 2001
Actual Primary Completion Date : January 2002


Arm Intervention/treatment
Experimental: WAL 801 CL Dry Syrup + Placebo Drug: WAL 801 CL Dry Syrup
Drug: Ketotifen Fumarate Dry Syrup placebo
Active Comparator: Ketotifen Fumarate Dry Syrup + Placebo Drug: Ketotifen Fumarate Dry Syrup
Drug: WAL 801 CL Dry Syrup placebo



Primary Outcome Measures :
  1. Degree of pruritus [ Time Frame: at week 4 ]

Secondary Outcome Measures :
  1. Degree of pruritus [ Time Frame: at week 2 ]
  2. Degree of rash [ Time Frame: at weeks 2 and 4 ]
  3. Pruritus score obtained through the itching questionnaire [ Time Frame: at weeks 2 and 4 ]
  4. Impression on pruritus of the patient or the parent [ Time Frame: at week 4 ]
  5. Occurrence of adverse events [ Time Frame: up to 4 weeks ]
  6. Number of patients with abnormal changes from baseline in laboratory measurements (hematological tests, blood biochemical tests, and urinalysis) [ Time Frame: Baseline and week 4 ]


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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, patients must be pediatric atopic dermatitis patients that meet the following criteria and thus be appropriate for observation of pruritus. Diagnosis of atopic dermatitis was 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
  • One week or longer has passed since the patient started to use an external steroid preparation at "Strong" or lower grade, or stopped using any external steroid preparation, at the time of obtainment of consent from the patient
  • Pruritus with "2" or higher grade, immediately before initial 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 "Very Strong" or higher grade 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
  • Present and past history of convulsive disorder, such as epilepsy (convulsion threshold values may be lowered by the reference drug, Ketotifen Fumarate)
  • Clinically significant hepatic, renal, or cardiac disease or other complications: therefore, judgement that the patient is ineligible for inclusion in this study (Please note that 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: NCT02182557     History of Changes
Other Study ID Numbers: 262.259
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
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ketotifen
Epinastine
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents