Table 3.
Mean AUC of the NRS of pain intensity over time using wWOCF (ITT population)
| Saline placebo (n = 82) | Bupivacaine HCl 75 mg (n = 172) | HTX-011 300 mg/9 mg (n = 164) | |
|---|---|---|---|
| AUC0–8 | |||
| Mean (SD) | 50.0 (15.03) | 34.4 (16.31) | 30.6 (18.87) |
| p value versus saline placebo | < 0.0001 | < 0.0001 | |
| p value versus bupivacaine HCl | 0.0426 | ||
| AUC0–12 | |||
| Mean (SD) | 75.3 (24.59) | 57.7 (24.88) | 46.3 (29.31) |
| p value versus saline placebo | < 0.0001 | < 0.0001 | |
| p value versus bupivacaine HCl | 0.0001 | ||
| AUC0–24 | |||
| Mean (SD) | 143.8 (54.94) | 126.7 (52.68) | 97.7 (60.31) |
| p value versus saline placebo | 0.0238 | < 0.0001 | |
| p value versus bupivacaine HCl | < 0.0001 | ||
| AUC24–72 | |||
| Mean (SD) | 207.1 (122.32) | 215.2 (111.97) | 171.7 (120.40) |
| p value versus saline placebo | 0.6041 | 0.0264 | |
| p value versus bupivacaine HCl | 0.0007 | ||
| AUC0–72 | |||
| Mean (SD) | 350.8 (171.22) | 341.9 (158.30) | 269.4 (173.72) |
| p value versus saline placebo | 0.6902 | 0.0004 | |
| p value versus bupivacaine HCl | < 0.0001 | ||
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 (ANOVA) with randomized treatment as the main effect
AUC area under the curve, HCl hydrochloride, ITT intent to treat, NRS Numeric Rating Scale of the pain intensity score, SD standard deviation