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Phase 1 Thorough QT Study in Young Healthy Volunteers — TQT  

Postoperative Pain Clinical Trial

Official title:
Evaluation of the Effects of Therapeutic and Supra-therapeutic Single Doses of SKY0402 Given as Subcutaneous Injection on the QT/QTc Interval in Young Healthy Volunteers. A Prospective, Randomized, Placebo- and Positive-controlled, Double Blind, Single-centre, Crossover Phase 1 Study.

Clinical Trial Summary

A reduction in the postoperative need for opioids to enhance the recovery process and increase patient postoperative satisfaction.

Clinical Trial Description

Providing extended pain relief without the use of indwelling catheters is the basis for developing SKY0402. A formulation of bupivacaine, given as a single injection after surgery, that could provide adequate, continuous, and extended pain relief would greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize break-through episodes of pain. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00485667
Study type Interventional
Source Pacira Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 1
Start date June 2007
Completion date August 2007
View Details
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