Not Signed In -
Polyps |
|
|
Clinical Trial: Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)
This study is no longer recruiting patients.
|
Purpose
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 Sporadic Adenomatous Polyps | Drug: Celecoxib | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)
Further Study Details:
Primary Outcomes: 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.
Secondary Outcomes: The number of colorectal adenomas in study subjects the histopathologic grade of colorectal adenomas the size of colorectal adenomas measured after one year and three years of study drug use. In addition, the type, incidence, severity, timing, seriousnes
Expected Total Enrollment: 1500
Secondary Outcomes: The number of colorectal adenomas in study subjects the histopathologic grade of colorectal adenomas the size of colorectal adenomas measured after one year and three years of study drug use. In addition, the type, incidence, severity, timing, seriousnes
Expected Total Enrollment: 1500
Study start: March 2001
Eligibility
Ages Eligible for Study: 30 Years and above, Genders Eligible for Study: Both
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.
Location Information
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: EQ4-00-02-018
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00141193
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00141193
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Abdominal Pain (Cleveland Clinic)
- An Overview of Gastrointestinal Disorders (Cleveland Clinic)
email this page
print this page
bookmark this page
feedback on this page
