Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

December 13, 2007 updated by: Novartis

A Clinical Study Continued From the Confirmatory Study to Validate the Efficacy and Safety of Pimecrolimus Cream in Pediatric Atopic Dermatitis Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Various Cities, Japan
        • This study is not being conducted in the United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Names:
  • Elidel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety assessed by adverse events (AEs)

Secondary Outcome Measures

Outcome Measure
Number of flares during 26 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis Pharmaceuticals Japan, Novartis Pharmaceuticals Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Estimate)

December 17, 2007

Last Update Submitted That Met QC Criteria

December 13, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASM981C1302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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