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Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP) (PRESAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00141193
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : August 6, 2008
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Adenoma Drug: Celecoxib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1561 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Study Start Date : February 2001
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: A Drug: Celecoxib

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141193

  Show 106 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00141193     History of Changes
Other Study ID Numbers: EQ4-00-02-018
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents