Trial · NCT00582660
Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib
NCT00582660, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2014-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib. Trials, record NCT00582660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00582660
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib
- NCT number
- NCT00582660
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Colorectal Adenoma, Colorectal Carcinoma
- Interventions
- Celecoxib, Placebo
- First posted
- 2007-12-28
- Last updated
- 2017-06-15
- Results first posted
- 2014-08-07
- Limitations and caveats
- The most prominent factor that limited enrollment was this period of time was at the point that the FDA released its finding about the possible cardiac risks associated with Rofecoxib (VIOXX).
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Witha Change (IMPROVEMENT) in Colo-rectal Adenocarcinoma as Measured by Cyclooxygenase-2 Activity After 7 Days of Celecoxib | baseline to 7 days | 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 be important in colorectal carcinogenesis: COX-1 and 2, MMP, 2 7, and 9, tissue inhibitor of metalloproteinases(TIMPs) 1 ans 2 and beta-catenin. |
| Primary | Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot | baseline to 72 hours | At 72 hours after start of treatment, the number of subjects with immunoblot demonstrated a 1.5 to 2 fold increase in 15-LOX-1 protein expression in human colorectal adenocarcinoma cell line with epithelial morphology(HT-29) and dihydrolipoamide dehydrogenase(DLD)-1 cells. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Witha Change (IMPROVEMENT) in Colo-rectal Adenocarcinoma as Measured by Cyclooxygenase-2 Activity After 7 Days of Celecoxib | baseline to 7 days | Participant | NUMBER | |
| PRIMARY | Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot | baseline to 72 hours | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Witha Change (IMPROVEMENT) in Colo-rectal Adenocarcinoma as Measured by Cyclooxygenase-2 Activity After 7 Days of Celecoxib | Celecoxib | 2.0 | Participant | ||
| Number of Subjects Witha Change (IMPROVEMENT) in Colo-rectal Adenocarcinoma as Measured by Cyclooxygenase-2 Activity After 7 Days of Celecoxib | Placebo | 2.0 | Participant | ||
| Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot | Celecoxib | 3.0 | 0.5 | Participants | |
| Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot | Placebo | 0 | 0.5 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Celecoxib | 20 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | COMPLETED | Celecoxib | 20 | |
| Overall Study | COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Celecoxib | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Celecoxib | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Celecoxib | 0 | 20 |
| Total, other adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | Celecoxib | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Celecoxib vs Placebo: Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot | Trial comparisons |
| Celecoxib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00582660
GET https://conductscience.org/api/trials/v1/NCT00582660/registered