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Trial record 2 of 4 for:    "Colorectal Adenoma" | "Cyclooxygenase 2 Inhibitors"

Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib (UAB0040)

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ClinicalTrials.gov Identifier: NCT00582660
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : August 7, 2014
Last Update Posted : June 15, 2017
Sponsor:
Collaborators:
Pfizer
Pharmacia
Information provided by (Responsible Party):
Marty Heslin, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Colorectal Adenoma
Colorectal Carcinoma
Interventions Drug: Celecoxib
Drug: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description 400 mg BID given for 7 days before surgery 1 tablet BID given for 7 days before surgery
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Celecoxib Placebo Total
Hide Arm/Group Description 400 mg BID given for 7 days before surgery 1 tablet BID given for 7 days before surgery Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
62  (1) 62  (1) 62  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
6
  30.0%
4
  20.0%
10
  25.0%
Male
14
  70.0%
16
  80.0%
30
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Number of Subjects Witha Change (IMPROVEMENT) in Colo-rectal Adenocarcinoma as Measured by Cyclooxygenase-2 Activity After 7 Days of Celecoxib
Hide Description 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.
Time Frame baseline to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:
400 mg BID given for 7 days before surgery
1 tablet BID given for 7 days before surgery
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participant
2.0 2.0
2.Primary Outcome
Title Subjects With Positive Response 72 Hours After Administration of Study Treatment as Measured by Immunoblot
Hide Description 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.
Time Frame baseline to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description:
400 mg BID given for 7 days before surgery
1 tablet BID given for 7 days before surgery
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Participants
3.0 0
Time Frame From baseline visit to 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celecoxib Placebo
Hide Arm/Group Description 400 mg BID given for 7 days before surgery 1 tablet BID given for 7 days before surgery
All-Cause Mortality
Celecoxib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celecoxib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
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).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Martin J. Heslin M.D.
Organization: University of Alabama at Birmingham
Phone: 205-975-0450
EMail: marty.heslin@ccc.uab.edu
Layout table for additonal information
Responsible Party: Marty Heslin, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00582660     History of Changes
Other Study ID Numbers: F001228004
NQ8-00-02-008 ( Other Identifier: Pfizer Tracking Number )
First Submitted: December 20, 2007
First Posted: December 28, 2007
Results First Submitted: February 2, 2011
Results First Posted: August 7, 2014
Last Update Posted: June 15, 2017