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Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

Last updated on August 9, 2018

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Study Location
Pfizer Investigational Site
San Diego, California, 92123 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Adenoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- The subject has a history of Familial Adenomatous Polyposis or Hereditary
Non-Polyposis Colorectal Cancer.

- The subject has a history of inflammatory bowel disease.

NCT00141193
Pfizer
Completed
Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

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Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Colorectal Adenoma
Drug: Celecoxib
Placebo Comparator: A
Intervention: Drug: Celecoxib


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1561
May 2007
May 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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,   United States,   Uruguay
 
 
NCT00141193
EQ4-00-02-018
A3191107
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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