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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This study has been withdrawn prior to enrollment.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:
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
  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:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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 ] [ 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 ]

Estimated Enrollment: 4000
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01293656     History of Changes
Other Study ID Numbers: P08166
Study First Received: February 9, 2011
Last Updated: September 22, 2011
Health Authority: Russia: Ethics Committee

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

ClinicalTrials.gov processed this record on May 22, 2013