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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_005 |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0966; Rofecoxib / Duration of Treatment: 156 weeks | Drug | |||
| Placebo/ Duration of Treatment: 156 weeks | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer. | 156 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma | 156 Weeks | |
| Cumulative colorectal adenoma recurrence during treatment in all patients | 52 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15713943 | Background | Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA; Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med. 2005 Mar 17;352(11):1092-102. doi: 10.1056/NEJMoa050493. Epub 2005 Feb 15. | |
| 17087947 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Term |
|---|---|
| C116926 | rofecoxib |
| D000081206 | Duration of Therapy |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| To evaluate safety & tolerability of rofecoxib |
| Background |
| Baron JA, Sandler RS, Bresalier RS, Quan H, Riddell R, Lanas A, Bolognese JA, Oxenius B, Horgan K, Loftus S, Morton DG; APPROVe Trial Investigators. A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. Gastroenterology. 2006 Dec;131(6):1674-82. doi: 10.1053/j.gastro.2006.08.079. Epub 2006 Sep 1. |
| 17258718 | Background | Lanas A, Baron JA, Sandler RS, Horgan K, Bolognese J, Oxenius B, Quan H, Watson D, Cook TJ, Schoen R, Burke C, Loftus S, Niv Y, Ridell R, Morton D, Bresalier R. Peptic ulcer and bleeding events associated with rofecoxib in a 3-year colorectal adenoma chemoprevention trial. Gastroenterology. 2007 Feb;132(2):490-7. doi: 10.1053/j.gastro.2006.11.012. Epub 2006 Nov 10. |
| 18922570 | Derived | Baron JA, Sandler RS, Bresalier RS, Lanas A, Morton DG, Riddell R, Iverson ER, Demets DL. Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial. Lancet. 2008 Nov 15;372(9651):1756-64. doi: 10.1016/S0140-6736(08)61490-7. Epub 2008 Oct 14. |