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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)


Phase 3
30 Years
N/A
Not Enrolling
Both
Colorectal Adenoma

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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 SiteBlendora, California  91740
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535