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NCT00582660 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib
A Phase 2 study of Colorectal Carcinoma and Colorectal Adenoma, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00582660: Completed Phase 2 study of Colorectal Carcinoma and Colorectal Adenoma, sponsored by University of Alabama at Birmingham.
NCT00582660 is a Phase 2 study of Colorectal Carcinoma and Colorectal Adenoma that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants, below the 1,096-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00582660, a Phase 2 study of Colorectal Carcinoma and Colorectal Adenoma, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The Colo-Rectal adenocarcinoma will be measured by cyclooxygenase-2(COX-2) activity at 7 days post baseline. Cox-2 activity is measured by assessing tumors and normal tissue using "Electron microscope and Tandem mass Spectrometry" methodology though the UAB shared Mass Spectrometry facility. Improvement was measured by 2-fold increase in COX-2 activity from baseline. The methodology used was High Performance Liquid Chromatography(HPLC). additional studies include expression of genes thought to b
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Celecoxib
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2001-12 |
| Est. Completion | 2008-06 |
| Phase | Phase 2 |
What the finished NCT00582660 record still lists
NCT00582660 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,096-participant average among 53 other Colorectal Carcinoma trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Colorectal Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00582660 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT00582660 about?
NCT00582660 is a clinical study titled "Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib". 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....
What is the current status of trial NCT00582660?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2001-12. Estimated completion is 2008-06.
What conditions does trial NCT00582660 study?
This clinical trial studies the following conditions: Colorectal Carcinoma, Colorectal Adenoma.
What interventions are being tested in trial NCT00582660?
The interventions under investigation include: Placebo (DRUG), Celecoxib (DRUG).
Who is sponsoring clinical trial NCT00582660?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00582660 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00582660's enrollment target sits among peer trials
40 43rd of 53 higher than 10 of 53 other Colorectal Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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