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
Phase 3
40 Years
N/A
40 Years
N/A
Not Enrolling
Both
Colorectal Adenona
Both
Colorectal Adenona
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.
Outcome Time Frame:
156 Weeks
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2006_005
NCT ID:
NCT00282386
Start Date:
February 2000
Completion Date:
Related Keywords:
- Colorectal Adenona
- Adenoma
- Recurrence
Name | Location |
|---|
