Trial Outcomes & Findings for Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients (NCT NCT00335517)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

98 participants

Primary outcome timeframe

0-48 hours postoperatively

Results posted on

2014-12-19

Participant milestones
Measure	Injection DepoDur Injection
Overall Study STARTED	100
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	2

Withdrawal data not reported

Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients

Baseline characteristics by cohort
Measure	Injection n=98 Participants DepoDur Injection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants

Timeframe: 0-48 hours postoperatively

Outcome measures
Measure	Injection n=98 Participants DepoDur Injection
Number of Patients Enrolled and Recieving Injection	98 participants

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Injection n=98 participants at risk DepoDur Injection
Infections and infestations Draning Incision	2.0% 2/98 • Number of events 2 • 5 days
Cardiac disorders Pulmonary embolus	1.0% 1/98 • Number of events 1 • 5 days
Cardiac disorders Coronary atery disease	1.0% 1/98 • Number of events 1 • 5 days

University of Rochester

Phone: 585-275-8780