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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: January 24, 2006
Last updated: May 5, 2017
Last verified: May 2017
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.

Condition Intervention Phase
Colorectal Adenoma
Drug: MK0966; Rofecoxib / Duration of Treatment: 156 weeks
Drug: Placebo/ Duration of Treatment: 156 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer. [ Time Frame: 156 Weeks ]

Secondary Outcome Measures:
  • Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma [ Time Frame: 156 Weeks ]
  • Cumulative colorectal adenoma recurrence during treatment in all patients [ Time Frame: 52 Weeks ]
  • To evaluate safety & tolerability of rofecoxib

Enrollment: 2586
Actual Study Start Date: December 23, 1999
Study Completion Date: September 1, 2004
Primary Completion Date: September 1, 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00282386

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Study Data/Documents: CSR Synopsis  This link exits the site

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00282386     History of Changes
Other Study ID Numbers: 0966-122
Study First Received: January 24, 2006
Last Updated: May 5, 2017

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 25, 2017