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

Colorectal Adenoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282386
• Other study ID #: 0966-122
• Secondary ID: 2006_005
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2006
• Last updated: May 5, 2017
• Start date: December 23, 1999
• Est. completion date: September 1, 2004

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2586
• Est. completion date: September 1, 2004
• Est. primary completion date: September 1, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Recurrence

Intervention

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

• Placebo/ Duration of Treatment: 156 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.		156 Weeks
Secondary	Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma		156 Weeks
Secondary	Cumulative colorectal adenoma recurrence during treatment in all patients		52 Weeks
Secondary	To evaluate safety & tolerability of rofecoxib