Table 1.
Patient demographic and baseline characteristics
| Characteristic | Oral methylnaltrexone
|
Placebo (n=201) | ||
|---|---|---|---|---|
| 150 mg (n=201) | 300 mg (n=201) | 450 mg (n=200) | ||
| Mean age, years (SD) | 50.9 (10.3) | 51.5 (10.5) | 51.4 (10.5) | 52.6 (10.3) |
| Sex, n (%) | ||||
| Female | 133 (66.2) | 114 (56.7) | 128 (64.0) | 130 (64.7) |
| Male | 68 (33.8) | 87 (43.3) | 72 (36.0) | 71 (35.3) |
| Race, n (%) | ||||
| White | 164 (81.6) | 158 (78.6) | 172 (86.0) | 166 (82.6) |
| Black/African American | 30 (14.9) | 38 (18.9) | 25 (12.5) | 27 (13.4) |
| Other | 7 (3.5) | 5 (2.5) | 3 (1.5) | 8 (4.0) |
| Primary pain condition, n (%) | ||||
| Back pain | 132 (65.7) | 136 (67.7) | 135 (67.5) | 145 (72.1) |
| Arthritis | 20 (10.0) | 15 (7.5) | 19 (9.5) | 12 (6.0) |
| Neurologic/neuropathic pain | 16 (8.0) | 13 (6.5) | 16 (8.0) | 11 (5.5) |
| Joint/extremity pain | 13 (6.5) | 16 (8.0) | 11 (5.5) | 10 (5.0) |
| Fibromyalgia | 15 (7.5) | 8 (4.0) | 11 (5.5) | 12 (6.0) |
| Other | 5 (2.5) | 13 (6.5) | 8 (4.0) | 11 (5.5) |
| Baseline MED, mg/daya | 141.1 | 177.5 | 155.6 | 132.0 |
| Median (range) | (30.0–1280.0) | (47.4–2289.3) | (27.0–1272.0) | (42.6–1077.3) |
| Mean (SD) | 200.0 (205.2) | 252.6 (298.1) | 218.0 (189.1) | 209.7 (199.1) |
| Mean pain intensity score (SD) | 6.4 (1.8) | 6.4 (1.9) | 6.4 (1.9) | 6.2 (2.1) |
Notes:
a
Baseline opioid dose defined as average of daily oral MED during screening (within 30 days of first dose of study drug): calculated as (sum of total oral morphine equivalents during screening)/(number of days during screening).
Abbreviation: MED, morphine equivalent dose.