Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP) (PRESAP)
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| ClinicalTrials.gov Identifier: NCT00141193 |
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Recruitment Status :
Completed
First Posted : September 1, 2005
Last Update Posted : August 6, 2008
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Sponsor:
Pfizer
Information provided by:
Pfizer
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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 |
| Actual Primary Completion Date : | May 2007 |
| Actual Study Completion Date : | May 2007 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Celecoxib
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: A |
Drug: Celecoxib |
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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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Sponsors and Collaborators
Pfizer
Investigators
| 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 A3191107 |
| First Posted: | September 1, 2005 Key Record Dates |
| Last Update Posted: | August 6, 2008 |
| Last Verified: | August 2008 |
Additional relevant MeSH terms:
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Adenoma Adenomatous Polyps Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Celecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |