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This study has been withdrawn prior to enrollment.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

February 9, 2011
September 22, 2011
August 2011
July 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01293656 on ClinicalTrials.gov Archive Site
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Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166).
Cross-sectional Study of Inflammatory Bowel Disease Severity and Treatment Patterns in Eastern Europe, Middle East, and North Africa. (P08166)

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.

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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

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.

  • Inflammatory Bowel Disease
  • Crohn's Disease
  • Ulcerative Colitis
Other: No intervention.
There is no study intervention. Participants will be treated locally per site standards.
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
4000
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of Crohn's disease or ulcerative colitis.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01293656
P08166
No
Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Schering-Plough
Not Provided
Not Provided
Schering-Plough
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP