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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This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: February 9, 2011
Last updated: June 1, 2015
Last verified: June 2015
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 Intervention
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Other: No intervention.

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01293656     History of Changes
Other Study ID Numbers: P08166
Study First Received: February 9, 2011
Last Updated: June 1, 2015

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes processed this record on April 28, 2017