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| Sponsor: | University of Alabama at Birmingham |
|---|---|
| Collaborators: |
Pfizer Pharmacia |
| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00582660 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Adenoma Colorectal Carcinoma |
Drug: Celecoxib Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
| 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2001 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
7 day preoperative course of Celecoxib
|
Drug: Celecoxib
Celecoxib 400mg PO BID for 7 days prior to surgery.
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2: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo tablet BID for 7 days prior to surgery
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | Martin J Heslin, M.D. | University of Alabama at Birmingham |
More Information
| Responsible Party: | University of Alabama at Birmingham ( Martin Heslin, M.D./Associate Professor of Surgery ) |
| Study ID Numbers: | F001228004, NQ8-00-02-008 |
| Study First Received: | December 20, 2007 |
| Last Updated: | December 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00582660 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Rectal Diseases Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Digestive System Neoplasms Neoplasms by Histologic Type Celecoxib Cyclooxygenase Inhibitors |
Enzyme Inhibitors Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Adenoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
