CLINICAL TRIALS PROFILE FOR DEPODUR

All Clinical Trials for Depodur

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00335517 ↗	Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients	Completed	EKR Therapeutics, Inc	N/A	2006-06-01	The purpose of the study is to help determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.
NCT00335517 ↗	Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients	Completed	University of Rochester	N/A	2006-06-01	The purpose of the study is to help determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.
NCT00456638 ↗	Clinical Study of Depodur Efficacy in Decreasing Post Operative Pain After Off Pump Coronary Artery Bypass Grafting (OP-CABG)	Withdrawn	Drexel University College of Medicine	N/A	2008-04-01	The purpose of this study is to determine whether epidural Depodur alleviates the pain of OP-CABG surgery. This includes pain associated with sternotomy, retraction, dissection and other tissue insults, as well as the induced inflammatory system and effects from prolonged ventilation in the ICU setting.
NCT00708318 ↗	Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects	Completed	YM BioSciences	Phase 1	2001-10-01	This was a pilot, phase I, two-period, fasting, bioavailability, safety,and pharmacokinetic study evaluating single dose of i.v. fentanyl (200 µg) and single doses of 2 mL or 3 mL inhaled AeroLEF (500 µg/mL) delivered by nebulization with the AeroEclipse BAN device administered in normal healthy non-smoking subjects.
NCT00728832 ↗	A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2002-05-01	The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test dose administration on the PK profile of a single epidural dose of DepoDur (extended-release epidural morphine) in patients undergoing major upper abdominal surgery. A secondary objective was to evaluate the safety and efficacy profile.
NCT00728832 ↗	A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery	Completed	EKR Therapeutics, Inc	Phase 1	2002-05-01	The primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test dose administration on the PK profile of a single epidural dose of DepoDur (extended-release epidural morphine) in patients undergoing major upper abdominal surgery. A secondary objective was to evaluate the safety and efficacy profile.
NCT00762554 ↗	Depodur vs Fentanyl Infusion for Post-C/S Analgesia	Unknown status	Goodman, Evan, M.D.	N/A	2008-10-01	Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.

Clinical Trial Conditions for Depodur

Condition Name

Condition Name for Depodur
Intervention	Trials
Pain	1
Pain Management	1
Pain, Postoperative	1
Postoperative Pain	1

Condition MeSH

Condition MeSH for Depodur
Intervention	Trials
Pain, Postoperative	3
Scoliosis	1
Agnosia	1
Muscle Spasticity	1

Clinical Trial Locations for Depodur

Trials by Country

Trials by Country for Depodur
Location	Trials
United States	8
Canada	1

Trials by US State

Trials by US State for Depodur
Location	Trials
New York	2
Missouri	1
North Carolina	1
Kentucky	1
Colorado	1

Clinical Trial Progress for Depodur

Clinical Trial Phase

Clinical Trial Phase for Depodur
Clinical Trial Phase	Trials
Phase 4	4
Phase 1	2
N/A	5

Clinical Trial Status

Clinical Trial Status for Depodur
Clinical Trial Phase	Trials
Completed	5
Terminated	4
Withdrawn	1

Clinical Trial Sponsors for Depodur

Sponsor Name

Sponsor Name for Depodur
Sponsor	Trials
EKR Therapeutics, Inc	4
University of Colorado, Denver	1
University of Louisville	1

Sponsor Type

Sponsor Type for Depodur
Sponsor	Trials
Other	9
Industry	6