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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 30, 2005
Last updated: August 5, 2008
Last verified: August 2008
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 Intervention Phase
Colorectal Adenoma Drug: Celecoxib Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • The number of colorectal adenomas in study subjects [ Time Frame: 3 years ]
  • the histopathologic grade of colorectal adenomas [ Time Frame: 3 years ]
  • the size of colorectal adenomas measured after one year and three years of study drug use. [ Time Frame: 3 years ]

Enrollment: 1561
Study Start Date: February 2001
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: Celecoxib


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00141193

  Show 106 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

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

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00141193     History of Changes
Other Study ID Numbers: EQ4-00-02-018
Study First Received: August 30, 2005
Last Updated: August 5, 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 processed this record on August 22, 2017