A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence 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...

Date First Received: January 24, 2006

Last Updated: April 27, 2009

Verified by: Merck, April 2009

Clinical Trial Phase: Phase 3 | Start Date: February 2000

Overall Status: Completed

Estimated Enrollment: 2612

Brief Summary

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”

Condition Keyword(s):

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 (Subject, Investigator), 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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Sponsor Information

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Related Publications

References

Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA; Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med. 2005 Mar 17;352(11):1092-102. Epub 2005 Feb 15. Erratum in: N Engl J Med. 2006 Jul 13;355(2):221.

Baron JA, Sandler RS, Bresalier RS, Quan H, Riddell R, Lanas A, Bolognese JA, Oxenius B, Horgan K, Loftus S, Morton DG; APPROVe Trial Investigators. A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. Gastroenterology. 2006 Dec;131(6):1674-82. Epub 2006 Sep 1.

Lanas A, Baron JA, Sandler RS, Horgan K, Bolognese J, Oxenius B, Quan H, Watson D, Cook TJ, Schoen R, Burke C, Loftus S, Niv Y, Ridell R, Morton D, Bresalier R. Peptic ulcer and bleeding events associated with rofecoxib in a 3-year colorectal adenoma chemoprevention trial. Gastroenterology. 2007 Feb;132(2):490-7. Epub 2006 Nov 10.

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

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

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