NCT00232011

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

December 17, 2007

Status Verified

December 1, 2007

First QC Date

October 3, 2005

Last Update Submit

December 13, 2007

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, ASM981, pimecrolimus

Outcome Measures

Primary Outcomes (1)

  • Safety assessed by adverse events (AEs)

Secondary Outcomes (1)

  • Number of disease flares during 26 weeks of treatment

Study Arms (1)

1

EXPERIMENTAL
Drug: Pimecrolimus Cream 1%

Interventions

Pimecrolimus Cream 1%DRUG

Pimecrolimus cream 1 %

Also known as: Elidel
1

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who failed in treatment compliance in the core study
  • Patients who had a major violation of the protocol in the core study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

This study is not being conducted in the United States

Various Cities, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Novartis Pharmaceuticals Japan

    Novartis Pharmaceuticals Japan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Study Start

May 1, 2004

Study Completion

May 1, 2005

Last Updated

December 17, 2007

Record last verified: 2007-12

Locations

JP(1)