A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas (0966-122)
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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 large intestine, also known as the colon) in patients with a history of colorectal adenomas.
Condition or disease
Drug: MK0966; Rofecoxib / Duration of Treatment: 156 weeksDrug: Placebo/ Duration of Treatment: 156 weeks
A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study With In-House Blinding to Determine the Effect of 156 Weeks of Treatment With MK0966 on the Recurrence of Neoplastic Polyps of the Large Bowel in Patients With a History of Colorectal Adenomas
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Ages Eligible for Study:
40 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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