A Pharmacokinetic (PK) Study of Extended-Release Epidural Morphine in Upper Abdominal Surgery

Phase 1 Completed 39 enrolled EKR Therapeutics, Inc Pacira Pharmaceuticals, Inc · collab

RandomizedParallel-groupOpen-label

Summary

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.

Timeline

Start: 2002-05
Primary completion: 2003-02
Completion: —

Publications

Viscusi ER, Manvelian GZ. A randomized study of the serum pharmacokinetics of lower thoracic extended-release epidural morphine (DepoDur) after lidocaine-epinephrine test dose administration in patients undergoing upper abdominal surgery. Int J Clin Pharmacol Ther. 2009 Nov;47(11):659-70. doi: 10.5414/cpp47659.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Morphine	Other / unclassified	15 mg	Other
Background	Fentanyl	Other / unclassified	—	Intravenous

Indications

No indication recorded.