Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166).

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT01293656

First received: February 9, 2011

Last updated: September 22, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	February 9, 2011
Last Updated Date	September 22, 2011
Start Date ^ICMJE	August 2011
Estimated Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2011)	The number of participants with Crohn's Disease (CD) or ulcerative colitis (UC) who visit the participating sites. [ Time Frame: 1 Year ] [ Designated as safety issue: No ] The number of participants with different degrees of CD and UC severity. [ Time Frame: 1 Year ] [ Designated as safety issue: No ] Use rates of classes of drug therapy. [ Time Frame: 1 Year ] [ Designated as safety issue: No ] Number and types of surgical interventions. [ Time Frame: 1 Year ] [ Designated as safety issue: No ] Outcomes of surgical intervention. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01293656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166).
Official Title ^ICMJE	Cross-sectional Study of Inflammatory Bowel Disease Severity and Treatment Patterns in Eastern Europe, Middle East, and North Africa. (P08166)
Brief Summary	This study is being done to assess the clinical course and treatment options for Crohn's Disease (CD) and ulcerative colitis (UC) in the populations of Eastern Europe, Middle East, and North Africa.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	All patients with CD or UC who visit the study sites in Eastern Europe, Middle East, and North Africa during the study period will be asked to participate.
Condition ^ICMJE	Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis
Intervention ^ICMJE	Other: No intervention. There is no study intervention. Participants will be treated locally per site standards.
Study Group/Cohort (s)	CD and UC participants All participants with CD or UC visiting their physician over a period of one year, newly and already diagnosed, regardless of treatment pattern. Intervention: Other: No intervention.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	4000
Estimated Completion Date	July 2012
Estimated Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Confirmed diagnosis of Crohn's disease or ulcerative colitis.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01293656
Other Study ID Numbers ^ICMJE	P08166
Has Data Monitoring Committee	No
Responsible Party	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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