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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00282386
First received: January 24, 2006
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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 Adenona
Drug: MK0966; Rofecoxib / Duration of Treatment: 156 weeks
Drug: Placebo/ Duration of Treatment: 156 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Estimated Enrollment: 2612
Study Start Date: February 2000
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282386

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00282386     History of Changes
Other Study ID Numbers: 2006_005, MK0966-122
Study First Received: January 24, 2006
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Rofecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 15, 2014