A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas (0966-122)
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ClinicalTrials.gov Identifier: NCT00282386 |
Recruitment Status
:
Completed
First Posted
: January 26, 2006
Last Update Posted
: May 9, 2017
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Tracking Information | ||||
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First Submitted Date ICMJE | January 24, 2006 | |||
First Posted Date ICMJE | January 26, 2006 | |||
Last Update Posted Date | May 9, 2017 | |||
Actual Study Start Date ICMJE | December 23, 1999 | |||
Actual Primary Completion Date | September 1, 2004 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer. [ Time Frame: 156 Weeks ] | |||
Original Primary Outcome Measures ICMJE |
Cumulative colorectal adenoma recurrence during 156 weeks of treatment in patients with an increased risk to develop colorectal cancer. | |||
Change History | Complete list of historical versions of study NCT00282386 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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. | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study to Evaluate the Effect of MK0966 (Rofecoxib) on the Recurrence of Colorectal Adenomas (0966-122) | |||
Official Title ICMJE | 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 | |||
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 Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Colorectal Adenoma | |||
Intervention ICMJE |
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Study Arms | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
2586 | |||
Original Enrollment ICMJE |
2612 | |||
Actual Study Completion Date | September 1, 2004 | |||
Actual Primary Completion Date | September 1, 2004 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 40 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00282386 | |||
Other Study ID Numbers ICMJE | 0966-122 2006_005 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Merck Sharp & Dohme Corp. | |||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | |||
Verification Date | May 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |