Mean AUC of th NRS of pain intensity over time using wWOCF (ITT population)*
| Endpoint | Saline placebo (n = 100) | Bupivacaine HCl 50 mg (n = 155) | HTX-011 60 mg/1.8 mg (n = 157) |
| AUC0-8 | |||
| Mean (SD) | 37.55 (15.65) | 24.26 (14.23) | 20.68 (17.54) |
| P value versus saline placebo | <0.0001 | <0.0001 | |
| P value versus bupivacaine HCl | 0.0477 | ||
| AUC0-12 | |||
| Mean (SD) | 67.97 (22.98) | 50.37 (22.94) | 38.54 (28.08) |
| P value versus saline placebo | <0.0001 | <0.0001 | |
| P value versus bupivacaine HCl | <0.0001 | ||
| AUC0-24 | |||
| Mean (SD) | 155.75 (48.49) | 131.36 (48.86) | 98.65 (59.55) |
| P value versus saline placebo | 0.0004 | <0.0001 | |
| P value versus bupivacaine HCl | <0.0001 | ||
| AUC24-72 | |||
| Mean (SD) | 289.59 (115.64) | 262.09 (117.25) | 224.64 (131.28) |
| P value versus saline placebo | 0.0806 | <0.0001 | |
| P value versus bupivacaine HCl | 0.0072 | ||
| AUC0-72 | |||
| Mean (SD) | 445.34 (155.79) | 393.45 (153.76) | 323.29 (182.64) |
| P value versus saline placebo | 0.0151 | <0.0001 | |
| P value versus bupivacaine HCl | 0.0002 |
*ITT population includes all subjects who are randomized and received study drug. Analyzed using windowed worst observation carried forward (wWOCF). P values reflect results of an analysis of variance with randomized treatment as the main effect.
AUCx-y,area under the curve from x to y hours;HCl, hydrochloride;ITT, intent to treat;NRS, Numeric Rating Scale.