The purpose of this study is to assess how effective celecoxib is in limiting production of a hormone, prostaglandin, in the subject's body. It is felt that this hormone is involved in the evolution of pre-cancerous growths in the colon to cancerous stage or in the progression of an existing cancer. To answer this question, some subjects are given the new investigational drug, and other subjects...
Date First Received: December 20, 2007
Last Updated: December 27, 2007
Verified by: University of Alabama at Birmingham, September 2004
Clinical Trial Phase: Phase 2 | Start Date: December 2001
Overall Status: Completed
Estimated Enrollment: 120
Brief Summary
Official Title: “Randomized, Placebo-Controlled, Phase IIB Evaluation of Cyclooxygenase-2 Activity in Surgically Resected Primary Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to assess how effective celecoxib is in limiting production of a hormone, prostaglandin, in the subject's body. It is felt that this hormone is involved in the evolution of pre-cancerous growths in the colon to cancerous stage or in the progression of an existing cancer. To answer this question, some subjects are given the new investigational drug, and other subjects a placebo. A placebo is a capsule that contains inactive ingredients. Only by comparing the response of two subject groups, one receiving placebo (inactive), and one receiving celecoxib (active), will we be able to know whether or not celecoxib actually works. The outcome we are assessing is the hormone activity before and after celecoxib is given.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Study Primary Completion Date: June 2008
Intervention(s) in this Clinical Trial
- Drug: Celecoxib
- Celecoxib 400mg PO BID for 7 days prior to surgery.
- Drug: Placebo
- Placebo tablet BID for 7 days prior to surgery
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- 7 day preoperative course of Celecoxib
- Placebo Comparator: 2
- Placebo
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Colon mass
Exclusion Criteria:
- Allergic to aspirin
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 19 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University of Alabama at Birmingham
Overall Clinical Trial Officials and Contacts
Martin J Heslin, M.D. Principal Investigator University of Alabama at Birmingham
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00582660
Study ID Number: F001228004
ClinicalTrials.gov Identifier: NCT00582660
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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