Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00993226 | An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy | PHASE2 | COMPLETED | 115 | — | — | May 1, 2009 | Jul 1, 2010 | Jun 1, 2021 | 14 | France, Germany +4 |
| NCT00993798 | An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery | PHASE2 | COMPLETED | 107 | — | — | Apr 1, 2009 | Nov 1, 2011 | Jun 9, 2021 | 10 | Austria, Germany +3 |
Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. 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 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.
Cumulative IV morphine-equivalent dose of opioid rescue medication
| Arm | Type | Description |
|---|---|---|
| SABER-Bupivacaine Treatment 1a | EXPERIMENTAL | double-blind |
| Placebo SABER-Bupivacaine Treatment 1b | PLACEBO_COMPARATOR | double-blind |
| Bupivacaine HCl Treatment 1c | ACTIVE_COMPARATOR | double-blind |
| SABER-Bupivacaine Treatment 2a | EXPERIMENTAL | double-blind |
| Placebo SABER-Bupivacaine Treatment 2b | PLACEBO_COMPARATOR | double-blind |
| Bupivacaine HCl Treatment 2c | ACTIVE_COMPARATOR | double-blind |
| Name | Type | Description |
|---|---|---|
| SABER-Bupivacaine Treatment 1a | DRUG | 5.0 ml |
| Placebo SABER-Bupivacaine Treatment 1b | DRUG | 5.0 ml |
| Bupivacaine HCl Treatment 1c | DRUG | 40 ml |
| SABER-Bupivacaine Treatment 2a | DRUG | 7.5 ml |
| Placebo SABER-Bupivacaine Treatment 2b | DRUG | 7.5 ml |
| Bupivacaine HCl Treatment 2c | DRUG | 40 ml |
Inclusion Criteria: * A planned elective, abdominal hysterectomy * Patients suitable for general anaesthesia Exclusion Criteria: * Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities *...