Extension Study to Assess Safety and Efficacy of Pimecrol... | NCT00232011

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

NCT00232011

Sponsor

Novartis

Status

Completed

Last Update Posted

Dec 17, 2007Estimated

Enrollment

160

Phase

Phase 3

Conditions

Atopic Dermatitis

Interventions

Pimecrolimus Cream 1%

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

May 2005Actual

First Submitted Date

Oct 3, 2005

First Submission Date that Met QC Criteria

Oct 3, 2005

First Posted Date

Oct 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2007

Last Update Posted Date

Dec 17, 2007Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Pimecrolimus Cream 1%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pimecrolimus Cream 1%	Drug	Pimecrolimus cream 1 %	1	Elidel

Measure	Description	Time Frame
Safety assessed by adverse events (AEs)

Measure	Description	Time Frame
Number of disease flares during 26 weeks of treatment

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals Japan	Novartis Pharmaceuticals Japan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
This study is not being conducted in the United States		Various Cities			Japan

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C117268	pimecrolimus

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided