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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01293656
Recruitment Status : Withdrawn
First Posted : February 10, 2011
Last Update Posted : June 2, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Other: No intervention.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cross-sectional Study of Inflammatory Bowel Disease Severity and Treatment Patterns in Eastern Europe, Middle East, and North Africa. (P08166)
Study Start Date : August 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.
Other: No intervention.
There is no study intervention. Participants will be treated locally per site standards.

Primary Outcome Measures :
  1. The number of participants with Crohn's Disease (CD) or ulcerative colitis (UC) who visit the participating sites. [ Time Frame: 1 Year ]
  2. The number of participants with different degrees of CD and UC severity. [ Time Frame: 1 Year ]
  3. Use rates of classes of drug therapy. [ Time Frame: 1 Year ]
  4. Number and types of surgical interventions. [ Time Frame: 1 Year ]
  5. Outcomes of surgical intervention. [ Time Frame: 1 Year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • Confirmed diagnosis of Crohn's disease or ulcerative colitis.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01293656     History of Changes
Other Study ID Numbers: P08166
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes