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

Phase 3

Completed

• Conditions: Colorectal Adenoma

• Registration Number: NCT00282386
• Lead Sponsor: Merck Sharp & Dohme LLC

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12-23
• Primary Completion: 2004-09-01
• Study Completion: 2004-09-01
• Study First Submitted: 2006-01-24
• Study First Submitted QC: 2006-01-24
• Study First Posted: 2006-01-26
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2586

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.	156 Weeks

Secondary Outcome Measures

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