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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00232011

First received: October 3, 2005

Last updated: December 13, 2007

Last verified: December 2007

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Clinical Study Continued From the Confirmatory Study to Assess the Efficacy and Safety of ASM981 Cream in Adult Atopic Dermatitis Patients

Resource links provided by NLM:

Drug Information available for: Pimecrolimus

U.S. FDA Resources

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
Experimental: 1	Drug: Pimecrolimus Cream 1% Pimecrolimus cream 1 % Other Name: Elidel

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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	Novartis Pharmaceuticals Japan

More Information

No publications provided


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

Keywords provided by Novartis:


Atopic dermatitis, ASM981, pimecrolimus

Additional relevant MeSH terms:


Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Pimecrolimus Analgesics Analgesics, Non-Narcotic	Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents Central Nervous System Agents Dermatologic Agents Immunologic Factors Immunosuppressive Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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