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NCT01293656 Clinical Trial

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

Ulcerative Colitis Clinical Trial

Official title:
Cross-sectional Study of Inflammatory Bowel Disease Severity and Treatment Patterns in Eastern Europe, Middle East, and North Africa. (P08166)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01293656
Other study ID # P08166
Secondary ID
Status Withdrawn
Phase N/A
First received February 9, 2011
Last updated June 1, 2015
Start date August 2011
Est. completion date July 2012

Study information
Verified date June 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Other:
• No intervention.
There is no study intervention. Participants will be treated locally per site standards.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary The number of participants with Crohn's Disease (CD) or ulcerative colitis (UC) who visit the participating sites. 1 Year No
Primary The number of participants with different degrees of CD and UC severity. 1 Year No
Primary Use rates of classes of drug therapy. 1 Year No
Primary Number and types of surgical interventions. 1 Year No
Primary Outcomes of surgical intervention. 1 Year No
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