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

Tracking Information
First Submitted Date ICMJE	January 24, 2006
First Posted Date ICMJE	January 26, 2006
Last Update Posted Date	May 9, 2017
Actual Study Start Date ICMJE	December 23, 1999
Actual Primary Completion Date	September 1, 2004 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 2, 2007)	Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer. [ Time Frame: 156 Weeks ]
Original Primary Outcome Measures ICMJE; (submitted: January 24, 2006)	Cumulative colorectal adenoma recurrence during 156 weeks of treatment in patients with an increased risk to develop colorectal cancer.
Change History	Complete list of historical versions of study NCT00282386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 2, 2007)	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
Original Secondary Outcome Measures ICMJE; (submitted: January 24, 2006)	Cumulative colorectal adenoma recurrence during 156 weeks of treatment in patients with a history of colorectal adenoma.Cumulative colorectal adenoma recurrence during 52 weeks of treatment in all patients. To evaluate safety & tolerability of rofecoxib.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas (0966-122)
Official Title ICMJE	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
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
Condition ICMJE	Colorectal Adenoma
Intervention ICMJE	Drug: MK0966; Rofecoxib / Duration of Treatment: 156 weeks; Drug: Placebo/ Duration of Treatment: 156 weeks
Study Arms	Not Provided
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.; 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. doi: 10.1016/S0140-6736(08)61490-7. Epub 2008 Oct 14. Erratum in: Lancet. 2008 Nov 15;372(9651):1732.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 23, 2014)	2586
Original Enrollment ICMJE; (submitted: January 24, 2006)	2612
Actual Study Completion Date	September 1, 2004
Actual Primary Completion Date	September 1, 2004 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00282386
Other Study ID Numbers ICMJE	0966-122; 2006_005
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	May 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP