Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
NCT00141193 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1561
Last updated 2008-08-06
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.
Conditions
- Colorectal Adenoma
Interventions
- DRUG
-
Celecoxib
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-02-28
- Primary Completion
- 2007-05-31
- Completion
- 2007-05-31
Countries
- United States
- Australia
- Belgium
- Brazil
- Canada
- Chile
- China
- Czechia
- Denmark
- Finland
- France
- Germany
- Hong Kong
- Hungary
- Ireland
- Israel
- Italy
- Netherlands
- Norway
- Peru
- Poland
- Portugal
- Russia
- Singapore
- Slovakia
- South Africa
- Spain
- Sweden
- Switzerland
- Taiwan
- United Kingdom
- Uruguay
Study Locations
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