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WAL 801 CL Dry Syrup in Paediatric 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: NCT02182557
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 14, 2014
Study Start Date  ICMJE June 2001
Actual Primary Completion Date January 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
Degree of pruritus [ Time Frame: at week 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Degree of pruritus [ Time Frame: at week 2 ]
  • Degree of rash [ Time Frame: at weeks 2 and 4 ]
  • Pruritus score obtained through the itching questionnaire [ Time Frame: at weeks 2 and 4 ]
  • Impression on pruritus of the patient or the parent [ Time Frame: at week 4 ]
  • Occurrence of adverse events [ Time Frame: up to 4 weeks ]
  • Number of patients with abnormal changes from baseline in laboratory measurements (hematological tests, blood biochemical tests, and urinalysis) [ Time Frame: Baseline and week 4 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients
Official Title  ICMJE Phase III Double-Blind Comparative Study of WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Drug: WAL 801 CL Dry Syrup
  • Drug: Ketotifen Fumarate Dry Syrup
  • Drug: WAL 801 CL Dry Syrup placebo
  • Drug: Ketotifen Fumarate Dry Syrup placebo
Study Arms  ICMJE
  • Experimental: WAL 801 CL Dry Syrup + Placebo
    Interventions:
    • Drug: WAL 801 CL Dry Syrup
    • Drug: Ketotifen Fumarate Dry Syrup placebo
  • Active Comparator: Ketotifen Fumarate Dry Syrup + Placebo
    Interventions:
    • Drug: Ketotifen Fumarate Dry Syrup
    • Drug: WAL 801 CL Dry Syrup placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2014)
162
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02182557
Other Study ID Numbers  ICMJE 262.259
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP