Table 1.
Demographics and baseline characteristics (safety population)
| Characteristic | Open-label Titration Phase (N=110) | Double-blind Maintenance Phase
|
|
|---|---|---|---|
| Oxycodone DETERx (N=22) |
Placebo (N=22) |
||
| Age (years) | |||
| Mean (SD) | 49.1 (12.3) | 49.4 (14.4) | 50.8 (11.2) |
| Gender, n (%) | |||
| Male | 57 (51.8) | 9 (40.9) | 10 (45.5) |
| Female | 53 (48.2) | 13 (59.1) | 12 (54.5) |
| Race, n (%) | |||
| Caucasian/White | 86 (78.2) | 18 (81.8) | 18 (81.8) |
| Black or African American | 21 (19.1) | 3 (13.6) | 4 (18.2) |
| American Indian or Alaskan Native | 1 (0.9) | 1 (4.5) | 0 |
| Native Hawaiian or other Pacific Islander | 1 (0.9) | 0 | 0 |
| Other | 1 (0.9) | 0 | 0 |
| Ethnicity, n (%) | |||
| Hispanic/Latino | 5 (4.5) | 1 (4.5) | 2 (9.1) |
| Not Hispanic/Latino | 105 (95.5) | 21 (95.5) | 20 (90.9) |
| Height (cm) | |||
| Mean (SD) | 172.3 (10.9) | 169.6 (9.6) | 170.1 (11.2) |
| Weight (kg) | |||
| Mean (SD) | 91.5 (22.5) | 92.9 (22.1) | 88.7 (19.2) |
| BMI (kg/m2) | |||
| Mean (SD) | 30.7 (6.5) | 32.2 (6.9) | 30.6 (5.8) |
Abbreviation: BMI, body mass index.