Back to resultsExtension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Pimecrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, ASM981, pimecrolimus
Eligibility Criteria
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
Sites / Locations
- This study is not being conducted in the United States
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Safety assessed by adverse events (AEs)
Secondary Outcome Measures
Number of flares during 26 weeks of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00231998
Brief Title
Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, ASM981, pimecrolimus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (false)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Other Intervention Name(s)
Elidel
Intervention Description
Pimecrolimus cream 1 %
Primary Outcome Measure Information:
Title
Safety assessed by adverse events (AEs)
Secondary Outcome Measure Information:
Title
Number of flares during 26 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals Japan
Organizational Affiliation
Novartis Pharmaceuticals Japan
Official's Role
Study Chair
Facility Information:
Facility Name
This study is not being conducted in the United States
City
Various Cities
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis
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