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
  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:


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
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: 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 July 29, 2014