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

Purpose

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.

Condition	Intervention	Phase
Colorectal Adenona	Drug: MK0966; Rofecoxib / Duration of Treatment: 156 weeks Drug: Placebo/ Duration of Treatment: 156 weeks	Phase 3

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

Further study details as provided by Merck:

Primary Outcome Measures:

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

Secondary Outcome 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

Estimated Enrollment:	2612
Study Start Date:	February 2000
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282386

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Baron JA, Sandler RS, Bresalier RS, Lanas A, Morton DG, Riddell R, Iverson ER, Demets DL. Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. Lancet. 2008 Nov 15;372(9651):1756-64. Epub 2008 Oct 14.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00282386 History of Changes
Other Study ID Numbers:	2006_005, MK0966-122
Study First Received:	January 24, 2006
Last Updated:	May 21, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Adenoma
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Rofecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013