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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00282386

Enrollment

2586

Registered

2006-01-26

Start date

1999-12-23

Completion date

2004-09-01

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenoma

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.

Interventions

DRUGMK0966; Rofecoxib / Duration of Treatment: 156 weeks

DRUGPlacebo/ Duration of Treatment: 156 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.	156 Weeks

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026