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Completed

NCT Number: NCT00282386

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

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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Key information

Conditions

Colorectal Adenoma

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK0966; Rofecoxib / Duration of Treatment: 156 weeks

Drug

Placebo/ Duration of Treatment: 156 weeks

Drug

Primary outcomes

  1. Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.

    Time frame: 156 Weeks

Secondary outcomes

  1. Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma

    Time frame: 156 Weeks

  2. Cumulative colorectal adenoma recurrence during treatment in all patients

    Time frame: 52 Weeks

  3. To evaluate safety & tolerability of rofecoxib

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
Jan 26, 2006
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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