Table 3.
Summary of secondary endpoints from Randomization Baseline to Week 12 (intent-to-treat population)
| Secondary endpoint | Statistic | Oxycodone DETERx (N=22) | Placebo (N=22) | P-value |
|---|---|---|---|---|
| Responder analysisa | ||||
| >30%b | n (%) | 10 (45.5) | 0 (0.0) | 0.0004 |
| >50%b | n (%) | 10 (45.5) | 0 (0.0) | 0.0004 |
| Completers | n (%) | 14 (63.6) | 4 (18.2) | 0.0014c |
| Rescue medication | ||||
| Tablets per day | Mean (SD) | 0.16 (0.35) | 0.30 (0.59) | NAd |
| Dosage (mg) per day | Mean (SD) | 163.45 (337.83) | 216.20 (377.26) | NAd |
Notes:
a
Subjects who discontinued treatment or otherwise had missing data were considered non-responders. Responders were those subjects who had a Week 12 pain score ≥30% less than their screening baseline score.
b
Subjects with ≥30 or≥50% improvement.
c
P-value based on Kaplan–Meier time-to-exit analysis.
d
Rescue medication was reported using descriptive statistics.
Abbreviation: NA, not applicable.