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Completed

NCT Number: NCT00141193

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.

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Key information

Conditions

Colorectal Adenoma

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Townsville, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celecoxib

Drug

Primary outcomes

  1. 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.

    Time frame: 3 years

Secondary outcomes

  1. The number of colorectal adenomas in study subjects

    Time frame: 3 years

  2. the histopathologic grade of colorectal adenomas

    Time frame: 3 years

  3. the size of colorectal adenomas measured after one year and three years of study drug use.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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)

Acronym: PRESAP

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 1, 2005
Registry last updated
Aug 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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