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Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00231998
Collaborator
(none)
240
Enrollment
1
Location
1
Arm
13
Duration (Months)
18.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study following core study.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Study Continued From the Confirmatory Study to Validate the Efficacy and Safety of Pimecrolimus Cream in Pediatric Atopic Dermatitis Patients
Study Start Date :
May 1, 2004
Actual Study Completion Date :
Jun 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Names:
  • Elidel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety assessed by adverse events (AEs) []

    Secondary Outcome Measures

    1. Number of flares during 26 weeks of treatment []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 16 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
      • Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator

    • Patients whose guardians have given written informed consent to participation in this study

    Exclusion Criteria:
      • Patients who failed in treatment compliance in the core study

    • Patients who had a major violation of the protocol in the core study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 This study is not being conducted in the United States Various Cities Japan

    Sponsors and Collaborators

    • Novartis

    Investigators

    • Study Chair: Novartis Pharmaceuticals Japan, Novartis Pharmaceuticals Japan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00231998
    Other Study ID Numbers:
    • CASM981C1302
    First Posted:
    Oct 4, 2005
    Last Update Posted:
    Dec 17, 2007
    Last Verified:
    Dec 1, 2007
    Keywords provided by , ,
    Atopic dermatitis, ASM981, pimecrolimus
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema
    Pimecrolimus

    Study Results

    No Results Posted as of Dec 17, 2007