Table 2.
Adjusted mean (SE) POMWP (cm) change from baseline at day 2 evening, 1 h after drug application—FAS
| Treatment | N | Mean (SD) at baseline | Adjusted mean change (SE)a | Comparison vs. diclofenac + capsaicin | ||
|---|---|---|---|---|---|---|
| Adjusted mean of difference (SE)a,b | 95% CI | P value | ||||
| Placebo | 75 | 7.20 (1.246) | − 2.45 (0.252) | − 0.60 (0.277) | − 1.15, − 0.06 | 0.0303 |
| Capsaicin | 222 | 7.22 (1.159) | − 3.26 (0.160) | 0.21 (0.197) | − 0.18, 0.60 | 0.2886 |
| Diclofenac | 222 | 7.28 (1.271) | − 2.33 (0.160) | − 0.72 (0.197) | − 1.10, − 0.33 | 0.0003 |
| Diclofenac + capsaicin | 225 | 7.28 (1.148) | − 3.05 (0.159) | |||
CI confidence interval, FAS full analysis set, POMWP pain on movement worst procedure, SD standard deviation, SE standard error
aModel includes treatment, country, application site, time, treatment by time interaction, baseline POMWP and baseline POMWP by time interaction. A negative value indicates a decrease in POMWP (better health)
bNegative values are in favor of the combination treatment