CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
SABER-Bupivacaine +2 moredrug
Likely dose
SABER-Bupivacaine 2.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00974350
NCT00974350Phase 2Completed
CompareCT.gov

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

Durect·interventional·Posted Sep 10, 2009·Updated May 27, 2021

In Brief

A Phase 2 clinical trial evaluating SABER-Bupivacaine and SABER-Placebo for Postoperative Pain and 2 related conditions. Completed, enrolled 124 participants across 5 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain, Hernia, Surgery
CountriesAustralia, New Zealand
CollaboratorsNycomed

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 10, 2009
Enrollment StartJan 1, 2007
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.8 years ago

Interventions

SABER-Bupivacainedrug

Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once

SABER-Bupivacainedrug

Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once

SABER-Placebodrug

Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once