Clinical Trial: A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas (0966-122)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 P
Brief Summary: 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.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer. [ Time Frame: 156 Weeks ]
Original Primary Outcome: Cumulative colorectal adenoma recurrence during 156 weeks of treatment in patients with an increased risk to develop colorectal cancer.
Current Secondary Outcome:
- 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
Original Secondary Outcome: Cumulative colorectal adenoma recurrence during 156 weeks of treatment in patients with a history of colorectal adenoma.Cumulative colorectal adenoma recurrence during 52 weeks of treatment in all patients. To evaluate safety & tolerability of rofecoxib.
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: January 24, 2006
Date Started: December 23, 1999
Date Completion:
Last Updated: May 5, 2017
Last Verified: May 2017
