Text Size

Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00231998
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 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 Intervention Phase
Atopic Dermatitis
 Drug: Pimecrolimus
 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 Validate the Efficacy and Safety of Pimecrolimus Cream in Pediatric Atopic Dermatitis Patients

Resource links provided by NLM:

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 flares during 26 weeks of treatment

Estimated Enrollment: 240
Study Start Date: May 2004
Study Completion Date: June 2005
Arms Assigned Interventions
Experimental: 1 Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel

  Eligibility

Ages Eligible for Study:   2 Years to 16 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231998

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: NCT00231998     History of Changes
Other Study ID Numbers: CASM981C1302
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
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013