NCT00974350

A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair

A Double-Blind, Placebo-Controlled, Pharmacodynamic and Pharmacokinetic Dose Response Study of SABER-Bupivacaine Instilled Into the Wound in Patients Undergoing Open Inguinal Hernia Repair

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Durect · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia. The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.

Conditions

• Postoperative Pain
• Hernia
• Surgery

Interventions

Type	Name	Description
DRUG	SABER-Bupivacaine	Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once
DRUG	SABER-Bupivacaine	Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once
DRUG	SABER-Placebo	Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2009-09-10
• Last updated: 2021-05-27
• Results posted: 2021-05-05

Locations

5 sites across 2 countries: Australia, New Zealand