Overview

An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery

Status:
Completed

Trial end date:
2011-11-01

Target enrollment:

Participant gender:

Summary

The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on safety.

Phase:

Phase 2

Details

Lead Sponsor:

Durect

Collaborators:

Nycomed
Takeda

Treatments:

Bupivacaine