Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib
Information source: University of Alabama at Birmingham
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Adenoma; Colorectal Carcinoma
Intervention: Celecoxib (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s):
Martin J Heslin, M.D., Principal Investigator, Affiliation: University of Alabama at Birmingham
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Colon mass
Exclusion Criteria:
- Allergic to aspirin
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Additional Information
Starting date: December 2001
Last updated: December 27, 2007
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