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)
30 Years
N/A
Both
Colorectal Adenoma
Trial Information
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)
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
EQ4-00-02-018
NCT ID:
NCT00141193
Start Date:
February 2001
Completion Date:
May 2007
Related Keywords:
- Colorectal Adenoma
- Adenoma
- Adenomatous Polyps
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Westminster, Maryland 21157 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
