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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00141193
Other study ID # EQ4-00-02-018
Secondary ID A3191107
Status Completed
Phase Phase 3
First received August 30, 2005
Last updated August 5, 2008
Start date February 2001
Est. completion date May 2007

Study information

Verified date August 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Celecoxib


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

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, 

Outcome

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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