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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Adenoma

Intervention: MK0966; Rofecoxib / Duration of Treatment: 156 weeks (Drug); Placebo/ Duration of Treatment: 156 weeks (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.

Secondary outcome:

Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma

Cumulative colorectal adenoma recurrence during treatment in all patients

To evaluate safety & tolerability of rofecoxib

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Related publications:

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.

Starting date: February 2000
Last updated: April 24, 2014

Page last updated: August 23, 2015

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