Colorectal Adenoma Clinical Trial
— PRESAPOfficial title:
Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
| Verified date | August 2008 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1561 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years and older |
| Eligibility |
Inclusion Criteria: - The subject has had a documented colonoscopy to the cecum performed by a study-related physician with adequate preparation resulting in diagnosis and clearance of an adenomatous polyp(s) within 4 months prior to randomization. - The subject is willing to abstain from chronic use of all NSAIDs or COX-2 inhibitors excluding aspirin at cardioprotective doses for the duration of the study. Exclusion Criteria: - The subject has a history of Familial Adenomatous Polyposis or Hereditary Non-Polyposis Colorectal Cancer. - The subject has a history of inflammatory bowel disease. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Pfizer Investigational Site | Geelong | Victoria |
| Australia | Pfizer Investigational Site | Townsville | Queensland |
| Belgium | Pfizer Investigational Site | Brussels | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Gent | |
| Brazil | Pfizer Investigational Site | Porto Alegre | RS |
| Brazil | Pfizer Investigational Site | São Paulo | SP |
| Canada | Pfizer Investigational Site | Abbotsford | British Columbia |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Kingston | Ontario |
| Canada | Pfizer Investigational Site | London | Ontario |
| Canada | Pfizer Investigational Site | St. John's | |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Chile | Pfizer Investigational Site | Santiago | RM |
| China | Pfizer Investigational Site | Beijing | |
| China | Pfizer Investigational Site | Beijing | |
| Czech Republic | Pfizer Investigational Site | Brno | |
| Czech Republic | Pfizer Investigational Site | Hradec Kralove | |
| Czech Republic | Pfizer Investigational Site | Liberec | |
| Czech Republic | Pfizer Investigational Site | Prague | |
| Czech Republic | Pfizer Investigational Site | Prague | |
| Czech Republic | Pfizer Investigational Site | Prague 10 | |
| Czech Republic | Pfizer Investigational Site | Prague 6 | |
| Denmark | Pfizer Investigational Site | Arhus C | |
| Finland | Pfizer Investigational Site | Oulu | |
| France | Pfizer Investigational Site | Bobigny | |
| France | Pfizer Investigational Site | Lyon | |
| France | Pfizer Investigational Site | Marseille Cedex 09 | |
| France | Pfizer Investigational Site | Paris Cedex 14 | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Erlangen | |
| Germany | Pfizer Investigational Site | Freising | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Kuenzing | |
| Germany | Pfizer Investigational Site | Ludwigshafen | |
| Germany | Pfizer Investigational Site | Marburg | |
| Germany | Pfizer Investigational Site | Muenchen | |
| Germany | Pfizer Investigational Site | Munchen | |
| Germany | Pfizer Investigational Site | Ulm | |
| Hong Kong | Pfizer Investigational Site | Hong Kong | |
| Hong Kong | Pfizer Investigational Site | New Territories | |
| Hungary | Pfizer Investigational Site | Gyor | |
| Hungary | Pfizer Investigational Site | Szekszárd | |
| Ireland | Pfizer Investigational Site | Dublin | |
| Ireland | Pfizer Investigational Site | Wilton | Cork |
| Israel | Pfizer Investigational Site | Beer-Sheeva | |
| Israel | Pfizer Investigational Site | Hadera | |
| Israel | Pfizer Investigational Site | Haifa | |
| Israel | Pfizer Investigational Site | Hashomer | |
| Israel | Pfizer Investigational Site | Holon | |
| Israel | Pfizer Investigational Site | Jerusalem | |
| Israel | Pfizer Investigational Site | Petah-Tikva | |
| Israel | Pfizer Investigational Site | Tel-Aviv | |
| Italy | Pfizer Investigational Site | Brescia | |
| Italy | Pfizer Investigational Site | Milano | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | Roma | |
| Italy | Pfizer Investigational Site | San Giovanni Rotondo | Italy/Foggia/Italy |
| Italy | Pfizer Investigational Site | Siena | |
| Netherlands | Pfizer Investigational Site | Maastricht | |
| Norway | Pfizer Investigational Site | Skien | |
| Peru | Pfizer Investigational Site | Lima | |
| Poland | Pfizer Investigational Site | Warsaw | |
| Portugal | Pfizer Investigational Site | Lisboa | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Singapore | Pfizer Investigational Site | Singapore | |
| Singapore | Pfizer Investigational Site | Singapore | |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| South Africa | Pfizer Investigational Site | Cape Town | Western |
| South Africa | Pfizer Investigational Site | Johannesburg | Gauteng |
| South Africa | Pfizer Investigational Site | Johannesburg | Gauteng |
| South Africa | Pfizer Investigational Site | Johannesburg | Gauteng |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Oviedo | Asturias |
| Spain | Pfizer Investigational Site | Palma de Mallorca | Islas Baleares |
| Spain | Pfizer Investigational Site | San Sebastian | Guipuzcoa |
| Spain | Pfizer Investigational Site | Sevilla | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Uppsala | |
| Switzerland | Pfizer Investigational Site | Geneve 14 | |
| Taiwan | Pfizer Investigational Site | Kaohsiung | |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Harrow | Middlesex |
| United Kingdom | Pfizer Investigational Site | Newport | Gwent |
| United Kingdom | Pfizer Investigational Site | Oxford | |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | North Chicago | Illinois |
| United States | Pfizer Investigational Site | Oak Park | Illinois |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Kiego | California |
| Uruguay | Pfizer Investigational Site | Montevideo | |
| Uruguay | Pfizer Investigational Site | Montevideo | |
| Uruguay | Pfizer Investigational Site | Montevideo |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Uruguay, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes | |
| Secondary | The number of colorectal adenomas in study subjects | 3 years | No | |
| Secondary | the histopathologic grade of colorectal adenomas | 3 years | No | |
| Secondary | the size of colorectal adenomas measured after one year and three years of study drug use. | 3 years | No |
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