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Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

NCT ID: NCT00231998

Last Updated: 2007-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Atopic Dermatitis

Keywords

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Atopic dermatitis, ASM981, pimecrolimus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Pimecrolimus

Intervention Type DRUG

Pimecrolimus cream 1 %

Interventions

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Pimecrolimus

Pimecrolimus cream 1 %

Intervention Type DRUG

Other Intervention Names

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Elidel

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis Pharmaceuticals Japan

Role: STUDY_CHAIR

Novartis Pharmaceuticals Japan

Locations

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This study is not being conducted in the United States

Various Cities, , Japan

Site Status

Countries

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Japan

Other Identifiers

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CASM981C1302

Identifier Type: -

Identifier Source: org_study_id