A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas (0966-122)

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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 large intestine, also known as the colon) in patients with a history of colorectal adenomas.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Rofecoxib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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