Trials / Completed
CompletedNCT01052012
Bupivacaine Effectiveness and Safety in SABER® Trial
Bupivacaine Effectiveness and Safety in SABER Trial (BESST)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 331 (actual)
- Sponsor
- Durect · Industry
- Sex
- All
- Age
- 18 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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SABER-Bupivacaine | Injectable Extended Release Solution; SABER-Bupivacaine /Once |
| DRUG | Bupivacaine HCl | Injectable Solution; Bupivacaine HCl /Once |
| DRUG | SABER-Placebo | Injectable Solution; SABER-Placebo/Once |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2011-09-01
- Completion
- 2011-09-01
- First posted
- 2010-01-20
- Last updated
- 2021-06-01
- Results posted
- 2021-06-01
Locations
26 sites across 3 countries: United States, Australia, New Zealand
Source: ClinicalTrials.gov record NCT01052012. Inclusion in this directory is not an endorsement.