Status:
COMPLETED
Assessment of the Social Cost of Crohn's Disease: Economic and Quality of Life Aspects (Study P04560)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Inflammatory Bowel Disease
Crohn's Disease
Eligibility:
All Genders
18-70 years
Brief Summary
This observational study will evaluate the social cost and quality of life of participants who have had Crohn's Disease for at least 6 months and have active disease despite drug therapy. Participants...
Detailed Description
Participants for this study will be enrolled from 25 gastroenterology sites, even spread across Italy. Each center will enroll between 10 and 40 participants each.
Eligibility Criteria
Inclusion
- participant must:
- be between 18 and 70 years of age,
- have active Crohn's disease (CD) with CDAI score \>= 150 (as per amended protocol) in spite of drug therapy, or active fistulizing disease,
- be diagnosed with CD for at least 6 months,
- sign the informed consent,
- be capable of understanding the study and replying to the questionnaires.
Exclusion
- Participants who are unreliable in filling out questionnaires,
- Participants with diseases which may interfere with the cost's of CD or its complications,
- Participants who are participating in a clinical trial
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00723840
Start Date
September 1 2006
End Date
December 1 2009
Last Update
July 30 2015
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