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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Colorectal Adenoma

Treatments

Drug: Placebo/ Duration of Treatment: 156 weeks

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00282386

2006_005

0966-122

Details and patient eligibility

About

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.

Enrollment

2,586 patients

Sex

All

Ages

40+ years old

Volunteers

No 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