Table 1 Subject characteristics: ITT cohort

CharacteristicPlacebo, n = 77CR oxycodone, n = 82Total, n = 159
* 0 (no pain) to 10 (pain as bad as you can imagine).
† Twenty-two (92%) of 24 subjects who took anticonvulsants were taking gabapentin (mean baseline dose, 445 mg).
‡ Twenty-seven (77%) of 35 subjects who took tricyclic antidepressants were taking amitriptyline (mean baseline dose, 47 mg).
Male, n (%)38 (49.4)45 (54.9)83 (52.2)
White, n (%)62 (80.5)72 (87.8)134 (84.3)
Age, y, mean (SD)58.8 (12.4)59.0 (10.2)58.9 (11.3)
Screening HbA1C, %, mean (SD)7.9 (1.5)7.6 (1.4)7.8 (1.4)
Baseline pain intensity, mean (SD)*6.8 (1.3)6.9 (1.4)6.9 (1.4)
Prior or concomitant medications
    Opioid analgesics, n (%)7 (9.1)12 (14.6)19 (11.9)
    Nonopioid analgesics, n (%)61 (79.2)72 (87.8)133 (83.6)
    Adjuvant pain medications, n (%)47 (61.0)47 (57.3)94 (59.1)
        Anticonvulsants10 (13.0)14 (17.1)24 (15.1)
        Tricyclic antidepressants17 (22.1)18 (22.0)35 (22.0)
        Other antidepressants10 (13.0)16 (19.5)26 (16.4)
        Benzodiazepines6 (7.8)9 (11.0)15 (9.4)
        Other adjuvants19 (24.7)20 (24.4)39 (24.5)
    Diabetes medications, n (%)74 (96.1)75 (91.5)149 (93.7)