Status:
COMPLETED
A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas (0966-122)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Colorectal Adenoma
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This study was to compare the effect of 156 weeks of treatment with MK-0966 (Rofecoxib) versus placebo on the recurrence of colorectal adenomas (growths that occur on the inside (the lining) of the la...
Eligibility Criteria
Inclusion
- Eligible patients must have undergone a complete colonoscopy within 12 weeks of study entry with removal of all polyps; at least one polyp must have been confirmed a large bowel pre-cancerous polyp (adenoma) by the study pathologist.
Exclusion
- History with a specific hereditary large bowel polyp syndrome
- History of a large bowel adenoma before age 35
- Small or large bowel resection or history of inflammatory bowel disease
- History of cancer within the five years before enrollment
- Expected need for chronic NSAID therapy
- Positive test result for stool occult blood
- Uncontrolled hypertension, stroke or temporary mini stroke (TIA) within the past 2 years, angina or congestive heart failure with symptoms that occur at rest or with minimal activity
- History of myocardial infarction (heart attack), coronary angioplasty, or coronary artery bypass grafting within the past 1 year
- Pregnancy
Key Trial Info
Start Date :
December 23 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
2586 Patients enrolled
Trial Details
Trial ID
NCT00282386
Start Date
December 23 1999
End Date
September 1 2004
Last Update
May 9 2017
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