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NCT01052012 · ClinicalTrials.gov registry record · Phase 3
Bupivacaine Effectiveness and Safety in SABER® Trial
A Phase 3 study of Postoperative Pain and Abdominal Surgery, sponsored by Durect.
- Completed
- Registry status
- Phase 3
- Development phase
- 331
- Enrollment target
- 20
- Study locations
NCT01052012: Completed Phase 3 study of Postoperative Pain and Abdominal Surgery, sponsored by Durect.
NCT01052012 is a Phase 3 study of Postoperative Pain and Abdominal Surgery that has completed, run by Durect. The registered enrollment target is 331 participants, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (45% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01052012, a Phase 3 study of Postoperative Pain and Abdominal Surgery, has completed, sponsored by Durect.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 331 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for be
Conditions Studied
Interventions
- DRUG Bupivacaine HCl
- DRUG SABER-Bupivacaine
- DRUG SABER-Placebo
Study Locations (20)
Alabama
- DURECT Study Site - Birmingham
- DURECT Study Site - Florence
- DURECT Study Site - Mobile
- DURECT Study Site - Mobile
- DURECT Study Site - Montgomery
- DURECT Study Site - Sheffield
California
- DURECT Study Site - Arcadia
- DURECT Study Site - Fontana
- DURECT Study Site - Laguna Hills
- DURECT Study Site - Pasadena
Florida
- DURECT Study Site - Tampa
Georgia
- DURECT Study Site - Powder Springs
Indiana
- DURECT Study Site - Indianapolis
Massachusetts
- DURECT Study Site - Boston
Michigan
- DURECT Study Site - Troy
Minnesota
- DURECT Study Site - Duluth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-09 |
| Phase | Phase 3 |
What the finished NCT01052012 record still lists
NCT01052012 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (45% higher).
The record links to 2 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 3 interventions - of which Bupivacaine HCl is the first listed.
NCT01052012 names 20 study sites across 12 states, led by Alabama, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01052012 about?
NCT01052012 is a clinical study titled "Bupivacaine Effectiveness and Safety in SABER® Trial". 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...
What is the current status of trial NCT01052012?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2009-12. Estimated completion is 2011-09.
What conditions does trial NCT01052012 study?
This clinical trial studies the following conditions: Postoperative Pain, Abdominal Surgery.
What interventions are being tested in trial NCT01052012?
The interventions under investigation include: Bupivacaine HCl (DRUG), SABER-Bupivacaine (DRUG), SABER-Placebo (DRUG).
Who is sponsoring clinical trial NCT01052012?
This trial is sponsored by Durect, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01052012 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01052012's enrollment target sits among peer trials
331 16th of 120 higher than 104 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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