NCT00282386

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,586

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 1999

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 1999

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2006

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

4.7 years

First QC Date

January 24, 2006

Last Update Submit

May 5, 2017

Conditions

Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

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

    156 Weeks

Secondary Outcomes (3)

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

    156 Weeks

  • Cumulative colorectal adenoma recurrence during treatment in all patients

    52 Weeks

  • To evaluate safety & tolerability of rofecoxib

Interventions

MK0966; Rofecoxib / Duration of Treatment: 156 weeksDRUG
Placebo/ Duration of Treatment: 156 weeksDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 15713943BACKGROUND

  • 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.

    PMID: 17087947BACKGROUND

  • 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.

    PMID: 17258718BACKGROUND

  • 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.

    PMID: 18922570DERIVED

MeSH Terms

Interventions

rofecoxibDuration of Therapy

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 26, 2006

Study Start

December 23, 1999

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

May 9, 2017

Record last verified: 2017-05