Table 2.
Adverse events occurring in >5 % of study subjects during assessment phase
| Adverse event | Placebo (n = 24) | sOXN (n = 24) | OXY (n = 23) |
|---|---|---|---|
| Any | 5 (20.8) | 7 (29.2) | 22 (95.7) |
| Feeling hot | 1 (4.2) | 4 (16.7) | 9 (39.1) |
| Headache | 2 (8.3) | 4 (16.7) | 1 (4.3) |
| Somnolence | 0 (0) | 4 (16.7) | 7 (30.4) |
| Euphoric mood | 0 (0) | 2 (8.3) | 17 (73.9) |
| Nausea | 0 (0) | 1 (4.2) | 2 (8.7) |
| Dizziness | 0 (0) | 0 (0) | 3 (13.0) |
| Pruritus generalized | 0 (0) | 0 (0) | 3 (13.0) |
| Vision blurred | 0 (0) | 0 (0) | 2 (8.7) |
| Pruritus localized | 0 (0) | 0 (0) | 2 (8.7) |
Note: Values are expressed as n (%)
OXY oxycodone 0.07 mg/kg, sOXN simulated oxycodone 0.07 mg/kg + naloxone 0.035 mg/kg