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| ID | Type | Description | Link |
|---|---|---|---|
| A3191107 |
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This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects of celecoxib in reducing the proportion of subjects with new colorectal adenomas post baseline polypectomy after Month 13 (Year 1) and Month 37 (Year 3) of study drug administration. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The number of colorectal adenomas in study subjects | 3 years | |
| the histopathologic grade of colorectal adenomas | 3 years | |
| the size of colorectal adenomas measured after one year and three years of study drug use. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | San Diego | California | 92123 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22386831 | Derived | Arber N, Lieberman D, Wang TC, Zhang R, Sands GH, Bertagnolli MM, Hawk ET, Eagle C, Coindreau J, Zauber A, Lanas A, Levin B. The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo. Clin Ther. 2012 Mar;34(3):569-79. doi: 10.1016/j.clinthera.2012.02.001. Epub 2012 Mar 2. | |
| 21503000 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 3 years |
| San Kiego |
| California |
| 92123 |
| United States |
| Pfizer Investigational Site | North Chicago | Illinois | 60064 | United States |
| Pfizer Investigational Site | Oak Park | Illinois | 60304 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21229 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19107-5244 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23249 | United States |
| Pfizer Investigational Site | Townsville | Queensland | 4812 | Australia |
| Pfizer Investigational Site | Geelong | Victoria | 3219 | Australia |
| Pfizer Investigational Site | Brussels | 1070 | Belgium |
| Pfizer Investigational Site | Brussels | 1090 | Belgium |
| Pfizer Investigational Site | Brussels | 1200 | Belgium |
| Pfizer Investigational Site | Ghent | 9000 | Belgium |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01509-900 | Brazil |
| Pfizer Investigational Site | Edmonton | Alberta | T6G 2B7 | Canada |
| Pfizer Investigational Site | Abbotsford British Columbia | British Columbia | V2S 3N5 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V5Z 1J3 | Canada |
| Pfizer Investigational Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Pfizer Investigational Site | Kingston | Ontario | K7L 5G2 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 4G5 | Canada |
| Pfizer Investigational Site | St. John's | A1B 3V6 | Canada |
| Pfizer Investigational Site | Santiago | RM | Chile |
| Pfizer Investigational Site | Beijing | 10053 | China |
| Pfizer Investigational Site | Beijing | 100730 | China |
| Pfizer Investigational Site | Brno | Czechia |
| Pfizer Investigational Site | Hradec Králové | 500 12 | Czechia |
| Pfizer Investigational Site | Liberec | 460 63 | Czechia |
| Pfizer Investigational Site | Prague | 10034 | Czechia |
| Pfizer Investigational Site | Prague | 11833 | Czechia |
| Pfizer Investigational Site | Prague | 16 02 | Czechia |
| Pfizer Investigational Site | Prague | Czechia |
| Pfizer Investigational Site | Arhus C | 8000 | Denmark |
| Pfizer Investigational Site | Oulu | FIN-90221 | Finland |
| Pfizer Investigational Site | Bobigny | 93009 | France |
| Pfizer Investigational Site | Lyon | 69008 | France |
| Pfizer Investigational Site | Marseille | 13274 | France |
| Pfizer Investigational Site | Paris | 75679 | France |
| Pfizer Investigational Site | Berlin | 13353 | Germany |
| Pfizer Investigational Site | Erlangen | 91052 | Germany |
| Pfizer Investigational Site | Freising | 85356 | Germany |
| Pfizer Investigational Site | Hamburg | Germany |
| Pfizer Investigational Site | Künzing | 94550 | Germany |
| Pfizer Investigational Site | Ludwigshafen | 67063 | Germany |
| Pfizer Investigational Site | Marburg | 35055 | Germany |
| Pfizer Investigational Site | München | 81669 | Germany |
| Pfizer Investigational Site | München | 81675 | Germany |
| Pfizer Investigational Site | Ulm | 89081 | Germany |
| Pfizer Investigational Site | Hong Kong | Hong Kong |
| Pfizer Investigational Site | New Territories | Hong Kong |
| Pfizer Investigational Site | Győr | 9023 | Hungary |
| Pfizer Investigational Site | Szekszárd | 7100 | Hungary |
| Pfizer Investigational Site | Wilton | Cork | Ireland |
| Pfizer Investigational Site | Dublin | Ireland |
| Pfizer Investigational Site | Beer-Sheeva | 84101 | Israel |
| Pfizer Investigational Site | Hadera | 38100 | Israel |
| Pfizer Investigational Site | Haifa | Israel |
| Pfizer Investigational Site | Hashomer | 52621 | Israel |
| Pfizer Investigational Site | Holon | 58100 | Israel |
| Pfizer Investigational Site | Jerusalem | 91120 | Israel |
| Pfizer Investigational Site | Petah Tikva | Israel |
| Pfizer Investigational Site | Tel Aviv | 64239 | Israel |
| Pfizer Investigational Site | San Giovanni Rotondo | Italy/Foggia/Italy | 71013 | Italy |
| Pfizer Investigational Site | Brescia | 25123 | Italy |
| Pfizer Investigational Site | Milan | 20141 | Italy |
| Pfizer Investigational Site | Roma | 00144 | Italy |
| Pfizer Investigational Site | Roma | 00153 | Italy |
| Pfizer Investigational Site | Siena | 53100 | Italy |
| Pfizer Investigational Site | Maastricht | 6229 HX | Netherlands |
| Pfizer Investigational Site | Skien | 3710 | Norway |
| Pfizer Investigational Site | Lima | Lima Province | L11 | Peru |
| Pfizer Investigational Site | Warsaw | 02-781 | Poland |
| Pfizer Investigational Site | Lisbon | 1099-023 | Portugal |
| Pfizer Investigational Site | Moscow | 103006 | Russia |
| Pfizer Investigational Site | Moscow | 113093 | Russia |
| Pfizer Investigational Site | Moscow | 115478 | Russia |
| Pfizer Investigational Site | Moscow | 117415 | Russia |
| Pfizer Investigational Site | Moscow | 123154 | Russia |
| Pfizer Investigational Site | Moscow | 129356 | Russia |
| Pfizer Investigational Site | Singapore | 119074 | Singapore |
| Pfizer Investigational Site | Singapore | 529889 | Singapore |
| Pfizer Investigational Site | Bratislava | 85107 | Slovakia |
| Pfizer Investigational Site | Bratislava | Slovakia |
| Pfizer Investigational Site | Johannesburg | Gauteng | 2157 | South Africa |
| Pfizer Investigational Site | Johannesburg | Gauteng | 2193 | South Africa |
| Pfizer Investigational Site | Johannesburg | Gauteng | South Africa |
| Pfizer Investigational Site | Cape Town | Western | 7708 | South Africa |
| Pfizer Investigational Site | Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Pfizer Investigational Site | Barcelona | Barcelona | 08036 | Spain |
| Pfizer Investigational Site | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Pfizer Investigational Site | Oviedo | Principality of Asturias | 33006 | Spain |
| Pfizer Investigational Site | Seville | Sevilla | 41071 | Spain |
| Pfizer Investigational Site | Stockholm | 116 91 Stockholm | Sweden |
| Pfizer Investigational Site | Uppsala | 75185 Uppala | Sweden |
| Pfizer Investigational Site | Geneva | 1211 | Switzerland |
| Pfizer Investigational Site | Kaohsiung City | 813 | Taiwan |
| Pfizer Investigational Site | Newport | Gwent | NP9 2UB | United Kingdom |
| Pfizer Investigational Site | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| Pfizer Investigational Site | Glasgow | G40SF | United Kingdom |
| Pfizer Investigational Site | Oxford | OX3 9DU | United Kingdom |
| Pfizer Investigational Site | Montevideo | 11600 | Uruguay |
| Pfizer Investigational Site | Montevideo | 1200 | Uruguay |
| Pfizer Investigational Site | Montevideo | Uruguay |
| Derived |
| Arber N, Spicak J, Racz I, Zavoral M, Breazna A, Gerletti P, Lechuga MJ, Collins N, Rosenstein RB, Eagle CJ, Levin B. Five-year analysis of the prevention of colorectal sporadic adenomatous polyps trial. Am J Gastroenterol. 2011 Jun;106(6):1135-46. doi: 10.1038/ajg.2011.116. Epub 2011 Apr 19. |
| 18378608 | Derived | Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31. |
| 16943401 | Derived | Arber N, Eagle CJ, Spicak J, Racz I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B; PreSAP Trial Investigators. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med. 2006 Aug 31;355(9):885-95. doi: 10.1056/NEJMoa061652. |
| 16943394 | Derived | Solomon SD, Pfeffer MA, McMurray JJ, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber AG, Bertagnolli MM, Arber N, Wittes J; APC and PreSAP Trial Investigators. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation. 2006 Sep 5;114(10):1028-35. doi: 10.1161/CIRCULATIONAHA.106.636746. |
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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