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NCT00232011 Clinical Trial

Extension Study to Assess Safety and Efficacy of Pimecrolimus in Adult Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
A Clinical Study Continued From the Confirmatory Study to Assess the Efficacy and Safety of ASM981 Cream in Adult Atopic Dermatitis Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00232011
Other study ID # CASM981C1304
Secondary ID
Status Completed
Phase Phase 3
First received October 3, 2005
Last updated December 13, 2007
Start date May 2004
Est. completion date May 2005

Study information
Verified date December 2007
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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 adult 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

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator

- Patients who had 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pimecrolimus Cream 1%
Pimecrolimus cream 1 %

Locations
Country Name City State
Japan This study is not being conducted in the United States Various Cities

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety assessed by adverse events (AEs)
Secondary Number of disease flares during 26 weeks of treatment
See also
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