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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This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293656
First Posted: February 10, 2011
Last Update Posted: June 2, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Crohn's disease or ulcerative colitis.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01293656     History of Changes
Other Study ID Numbers: P08166
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: June 2, 2015
Last Verified: June 2015

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