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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00282386

First received: January 24, 2006

Last updated: May 21, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 24, 2006

Last Updated Date

May 21, 2013

Start Date ^ICMJE

February 2000

Primary Completion Date

September 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

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

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)(COMPLETED)

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

Condition ^ICMJE

Colorectal Adenona

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

* 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

Enrollment ^ICMJE

2612

Completion Date

Not Provided

Primary Completion Date

September 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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00282386

Other Study ID Numbers ^ICMJE

2006_005, MK0966-122

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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