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Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients (DepoDur)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00335517
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : January 9, 2013
Last Update Posted : December 19, 2014
Sponsor:
Collaborator:
EKR Therapeutics, Inc
Information provided by (Responsible Party):
Edward Puzas, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lumbar Spine Surgery
Intervention Drug: DepoDur
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Injection
Hide Arm/Group Description DepoDur Injection
Period Title: Overall Study
Started 100
Completed 98 [1]
Not Completed 2
[1]
Due to pharmacy error two patients were enolled and recieved EREM, but were not included in analysis
Arm/Group Title Injection
Hide Arm/Group Description DepoDur Injection
Overall Number of Baseline Participants 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
<=18 years
0
   0.0%
Between 18 and 65 years
66
  67.3%
>=65 years
32
  32.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants
60  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
Female
59
  60.2%
Male
39
  39.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 98 participants
98
1.Primary Outcome
Title Number of Patients Enrolled and Recieving Injection
Hide Description [Not Specified]
Time Frame 0-48 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Injection
Hide Arm/Group Description:
DepoDur Injection
Overall Number of Participants Analyzed 98
Measure Type: Number
Unit of Measure: participants
98
Time Frame 5 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Injection
Hide Arm/Group Description DepoDur Injection
All-Cause Mortality
Injection
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Injection
Affected / at Risk (%) # Events
Total   0/98 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Injection
Affected / at Risk (%) # Events
Total   5/98 (5.10%)    
Cardiac disorders   
Pulmonary embolus * [1]  1/98 (1.02%)  1
Coronary atery disease * [2]  1/98 (1.02%)  1
Infections and infestations   
Draning Incision * [3]  2/98 (2.04%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Patient diagnosed with a pulmonary embolus on post-op day 1. Patient had a history of atrial fibrillation treated with warfarin. Patient was treated with IVC filters and heparin anticoagulation, restarted on warfarin and discharged home.
[2]
One patient with a history of coronary artery disease was discharged to rehab facility where they died five days after srugery secondary to a myocardial infarction
[3]
2 participants were readmitted and returned to the OR for irrigation, debridement, and reclosure of draining incision. One patient returned post operatively on day 11 and the other on day 19. All cultures were negative for infection.
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: Glenn Rectine, MD
Organization: University of Rochester
Phone: 585-275-8780
EMail: glenn_rectine@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Edward Puzas, University of Rochester
ClinicalTrials.gov Identifier: NCT00335517     History of Changes
Other Study ID Numbers: 11678
First Submitted: June 8, 2006
First Posted: June 12, 2006
Results First Submitted: February 16, 2012
Results First Posted: January 9, 2013
Last Update Posted: December 19, 2014