Inflammatory Bowel DiseaseNCT01293656
Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166)
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Confirmed diagnosis of Crohn's disease or ulcerative colitis.
Who cannot join
None listed.
About this study
Official title: 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.
- Being tested
- No intervention.
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
There is no study intervention. Participants will be treated locally per site standards.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with Crohn's Disease (CD) or ulcerative colitis (UC) who visit the participating sites.
Measured: 1 Year
The number of participants with different degrees of CD and UC severity.
Measured: 1 Year
Use rates of classes of drug therapy.
Measured: 1 Year
Number and types of surgical interventions.
Measured: 1 Year
Outcomes of surgical intervention.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293656
- Sponsor's protocol ID
- P08166
- Status last verified
- Jun 2015
- First submitted
- 9 Feb 2011
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study of Inflammatory Bowel Disease Severity and Treatment Patterns in Eastern Europe, Middle East, and North Africa. (P08166)
- ClinicalTrials.gov ID
- NCT01293656
- Acronym / sponsor ID
- P08166
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD and UC participants | – | Other: No intervention.All participants with CD or UC visiting their physician over a period of one year, newly and already diagnosed, regardless of treatment pattern. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Confirmed diagnosis of Crohn's disease or ulcerative colitis.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention.There is no study intervention. Participants will be treated locally per site standards. | Other | CD and UC participants |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with Crohn's Disease (CD) or ulcerative colitis (UC) who visit the participating sites. (time frame: 1 Year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.