Official Title: “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”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: MK0966; Rofecoxib / Duration of Treatment: 156 weeks
• Drug: Placebo/ Duration of Treatment: 156 weeks

Primary Measures

• Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.
  • Time Frame: 156 Weeks
    

Secondary Measures

• Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma
  • Time Frame: 156 Weeks
    
• Cumulative colorectal adenoma recurrence during treatment in all patients
  • Time Frame: 52 Weeks
    
• To evaluate safety & tolerability of rofecoxib

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00282386

Study ID Number: 2006_005

ClinicalTrials.gov Identifier: NCT00282386

Health Authority: United States: Food and Drug Administration