Extension Study to Assess Safety and Efficacy of Pimecrolimus in Adult Patients With Atopic Dermatitis - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00232011

Purpose

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

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Pimecrolimus Cream 1%	Phase III

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Clinical Study Continued From the Confirmatory Study to Assess the Efficacy and Safety of ASM981 Cream in Adult Atopic Dermatitis Patients

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety assessed by adverse events (AEs)

Secondary Outcome Measures:

Number of disease flares during 26 weeks of treatment

Estimated Enrollment:	160
Study Start Date:	May 2004
Study Completion Date:	May 2005

Arms	Assigned Interventions
1: Experimental	Drug: Pimecrolimus Cream 1% Pimecrolimus cream 1 %

Eligibility

Ages Eligible for Study:	16 Years to 65 Years
Genders Eligible for Study:	Both

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232011

Locations

Japan
This study is not being conducted in the United States
various cities, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals Japan

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CASM981C1304
Study First Received:	October 3, 2005
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00232011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Atopic dermatitis, ASM981, pimecrolimus

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate

Skin Diseases, Eczematous
Pimecrolimus
Tacrolimus
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009