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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2586 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-23

Study Completion Date

2004-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0966; Rofecoxib / Duration of Treatment: 156 weeks

Intervention Type DRUG

Placebo/ Duration of Treatment: 156 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No