CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 331 enrolled
Drug / intervention
SABER-Bupivacaine +2 moredrug
Likely dose
Not stated in 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/NCT01052012
NCT01052012Phase 3Completed
CompareCT.gov

Bupivacaine Effectiveness and Safety in SABER Trial (BESST)

Durect·interventional·Posted Jan 20, 2010·Updated Jun 1, 2021

In Brief

A Phase 3 clinical trial evaluating SABER-Bupivacaine, Bupivacaine HCl, and 1 other intervention for Postoperative Pain and Abdominal Surgery. Completed, enrolled 331 participants across 26 sites in 3 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. The purpose of this study is to investigate safety (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain, Abdominal Surgery
CountriesAustralia, New Zealand, United States
CollaboratorsNycomed, Hospira, now a wholly owned subsidiary of Pfizer

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2010
Enrollment StartDec 1, 2009
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.4 years ago

Interventions

SABER-Bupivacainedrug

Injectable Extended Release Solution; SABER-Bupivacaine /Once

Bupivacaine HCldrug

Injectable Solution; Bupivacaine HCl /Once

SABER-Placebodrug

Injectable Solution; SABER-Placebo/Once