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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Pimecrolimus Cream 1%
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, ASM981, pimecrolimus

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • This study is not being conducted in the United States

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Safety assessed by adverse events (AEs)

Secondary Outcome Measures

Number of disease flares during 26 weeks of treatment

Full Information

First Posted
October 3, 2005
Last Updated
December 13, 2007
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00232011
Brief Title
Extension Study to Assess Safety and Efficacy of Pimecrolimus in Adult Patients With Atopic Dermatitis
Official Title
A Clinical Study Continued From the Confirmatory Study to Assess the Efficacy and Safety of ASM981 Cream in Adult Atopic Dermatitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, ASM981, pimecrolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus Cream 1%
Other Intervention Name(s)
Elidel
Intervention Description
Pimecrolimus cream 1 %
Primary Outcome Measure Information:
Title
Safety assessed by adverse events (AEs)
Secondary Outcome Measure Information:
Title
Number of disease flares during 26 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals Japan
Organizational Affiliation
Novartis Pharmaceuticals Japan
Official's Role
Study Chair
Facility Information:
Facility Name
This study is not being conducted in the United States
City
Various Cities
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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