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

Primary Purpose

Colorectal Adenoma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0966; Rofecoxib / Duration of Treatment: 156 weeks
Placebo/ Duration of Treatment: 156 weeks
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Adenoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    January 24, 2006
    Last Updated
    May 5, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00282386
    Brief Title
    A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas (0966-122)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 23, 1999 (Actual)
    Primary Completion Date
    September 1, 2004 (Actual)
    Study Completion Date
    September 1, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Adenoma

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    2586 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0966; Rofecoxib / Duration of Treatment: 156 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo/ Duration of Treatment: 156 weeks
    Primary Outcome Measure Information:
    Title
    Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.
    Time Frame
    156 Weeks
    Secondary Outcome Measure Information:
    Title
    Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma
    Time Frame
    156 Weeks
    Title
    Cumulative colorectal adenoma recurrence during treatment in all patients
    Time Frame
    52 Weeks
    Title
    To evaluate safety & tolerability of rofecoxib

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15713943
    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. doi: 10.1056/NEJMoa050493. Epub 2005 Feb 15. Erratum In: N Engl J Med. 2006 Jul 13;355(2):221.
    Results Reference
    background
    PubMed Identifier
    17087947
    Citation
    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. doi: 10.1053/j.gastro.2006.08.079. Epub 2006 Sep 1.
    Results Reference
    background
    PubMed Identifier
    17258718
    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. doi: 10.1053/j.gastro.2006.11.012. Epub 2006 Nov 10.
    Results Reference
    background
    PubMed Identifier
    18922570
    Citation
    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.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

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

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