| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01052012 | Bupivacaine Effectiveness and Safety in SABER® Trial | PHASE3 | COMPLETED | 331 | — | — | Dec 1, 2009 | Sep 1, 2011 | Jun 1, 2021 | 26 | United States, Australia +1 |
| NCT00818363 | A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery | PHASE2 | COMPLETED | 60 | — | — | Dec 1, 2008 | Oct 1, 2009 | Jun 1, 2021 | 9 | Australia, New Zealand |
| NCT00974350 | A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair | PHASE2 | COMPLETED | 124 | — | — | Jan 1, 2007 | Oct 1, 2007 | May 27, 2021 | 5 | Australia, New Zealand |
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 better translation of the clinical treatment effect magnitude.
Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
Mean pain intensity on movement AUC (time normalized area under the curve) during the period 0 to 72 hours post-dose. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The pain intensity AUC on movement was computed for each subject using the standard trapezoidal rule. For the purpose of better clinical interpretability of the pain AUC, a normalized AUC was computed by dividing it using the time-interval length over which it was computed.
Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). 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 better translation of the clinical treatment effect magnitude.
| Arm | Type | Description |
|---|---|---|
| Active: SABER-Bupivacaine | EXPERIMENTAL | SABER-Bupivacaine |
| Comparator: Bupivacaine HCl | ACTIVE_COMPARATOR | Bupivacaine HCl |
| Placebo: SABER-Placebo | PLACEBO_COMPARATOR | SABER-Placebo |
| Group 1: SABER-Bupivacaine | EXPERIMENTAL | 5.0 mL SABER-Bupivacaine/Once |
| Group 2: SABER-Placebo | PLACEBO_COMPARATOR | 5.0 mL SABER-Placebo/Once |
| Group 2: SABER-Bupivacaine | EXPERIMENTAL | 5.0 mL SABER-Bupivacaine/Once |
| Group 3: SABER-Placebo | PLACEBO_COMPARATOR | 2.5 mL or 5.0 mL SABER-Placebo/Once |
| Name | Type | Description |
|---|---|---|
| SABER-Bupivacaine | DRUG | Injectable Extended Release Solution; SABER-Bupivacaine /Once |
| Bupivacaine HCl | DRUG | Injectable Solution; Bupivacaine HCl /Once |
| SABER-Placebo | DRUG | Injectable Solution; SABER-Placebo/Once |
Inclusion Criteria: * Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff * Males and females, 18 years of age and older scheduled to undergo elective general abdominal surgery * Patients mus...