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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: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 41 |
| Study Start Date: | December 2001 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
7 day preoperative course of Celecoxib for Colon Cancer that is surgically resectable
|
Drug: Celecoxib
Celebrex/Celecoxib 400mg PO twice a day for 7 days prior to surgery.
|
|
Placebo Comparator: 2
Placebo in a one to one randomization prior to surgery
|
Drug: Placebo
Placebo/Placebo tablet twice a day 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: | Martin Heslin, M.D./Associate Professor of Surgery, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00582660 History of Changes |
| Other Study ID Numbers: | F001228004, NQ8-00-02-008 |
| Study First Received: | December 20, 2007 |
| Last Updated: | September 28, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Adenoma Carcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents |
