Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166)
June 1, 2015 updated by: Merck Sharp & Dohme LLC
Cross-sectional Study of Inflammatory Bowel Disease Severity and Treatment Patterns in Eastern Europe, Middle East, and North Africa. (P08166)
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Confirmed diagnosis of Crohn's disease or ulcerative colitis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
There is no study intervention.
Participants will be treated locally per site standards.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The number of participants with Crohn's Disease (CD) or ulcerative colitis (UC) who visit the participating sites.
Time Frame: 1 Year
|
1 Year
|
|
The number of participants with different degrees of CD and UC severity.
Time Frame: 1 Year
|
1 Year
|
|
Use rates of classes of drug therapy.
Time Frame: 1 Year
|
1 Year
|
|
Number and types of surgical interventions.
Time Frame: 1 Year
|
1 Year
|
|
Outcomes of surgical intervention.
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Anticipated)
July 1, 2012
Study Completion (Anticipated)
July 1, 2012
Study Registration Dates
First Submitted
February 9, 2011
First Submitted That Met QC Criteria
February 9, 2011
First Posted (Estimate)
February 10, 2011
Study Record Updates
Last Update Posted (Estimate)
June 2, 2015
Last Update Submitted That Met QC Criteria
June 1, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P08166
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.