Baseline demographics and clinical characteristics for all randomised patients
| Cindunistat | |||
|---|---|---|---|
| 50 mg/day | 200 mg/day | Placebo | |
| N=485 | N=486 | N=486 | |
| Age (years) | |||
| Mean±SD | 61.0±8.7 | 60.8±8.6 | 61.3±9.1 |
| Range | 40–85 | 40–87 | 40–89 |
| Gender | |||
| Female | 383 (79.0) | 367 (75.5) | 364 (74.9) |
| Male | 102 (21.0) | 119 (24.5) | 122 (25.1) |
| Race | |||
| White | 389 (80.2) | 410 (84.4) | 405 (83.3) |
| Other | 96 (19.8) | 76 (15.6) | 81 (16.7) |
| BMI (kg/m2) | |||
| Mean±SD | 31.9±4.1 | 32.0±4.1 | 31.6±4.1 |
| Range | 24.4–40.3 | 23.7–40.1 | 24.6–40.5 |
| Region | |||
| N. America/Australia | 286 (59.0) | 262 (53.9) | 273 (56.2) |
| Europe | 142 (29.3) | 166 (34.2) | 152 (31.3) |
| S. America | 57 (11.8) | 58 (11.9) | 61 (12.6) |
| Time since diagnosis (years) | |||
| Mean±SD | 6.4±6.3 | 6.7±7.2 | 6.8±7.2 |
| Range | 0.1–43.9 | 0.0–44.0 | 0.0–62.0 |
| KLG | |||
| KLG≤2 | 216 (44.5) | 203 (41.8) | 222 (45.7) |
| KLG3 | 269 (55.5) | 283 (58.2) | 264 (54.3) |
| JSW (mm)* | |||
| Mean±SD | 3.17±0.75 | 3.20±0.74 | 3.22±0.71 |
| Range | 1.56–5.41 | 1.55–5.98 | 1.43–5.28 |
| WOMAC pain* (range 0–20) | |||
| Mean±SD | 8.0±3.9 | 7.4±3.9 | 7.6±4.0 |
| WOMAC physical function* (range 0–68) | |||
| Mean±SD | 27.6±13.9 | 26.5±13.2 | 27.4±13.8 |
| Patient global assessment of arthritic condition* (range 0–100) | |||
| 40.2±24.8 | 37.6±24.3 | 39.4±23.9 | |
| Concomitant analgesics† | |||
| NSAIDs/Coxibs/aspirin | 301 (62.1) | 292 (60.1) | 306 (63.0) |
| Acetaminophen | 100 (20.6) | 97 (20.0) | 94 (19.3) |
| SYSADOA | 41 (8.5) | 36 (7.4) | 40 (8.2) |
| Weak opioids | 32 (6.6) | 15 (3.1) | 22 (4.5) |
| Strong opioids | 4 (0.8) | 5 (1.0) | 3 (0.6) |
| Glucocorticoids | 1 (0.2) | 0 (0) | 1 (0.2) |
| None | 109 (22.5) | 133 (27.4) | 115 (23.7) |
Data are mean±SD (range) or n (%).
*Missing observations: JSW cindunistat 50 mg/day (n=4), cindunistat 200 mg/day (n=9), and placebo (n=5); WOMAC Pain cindunistat 50 mg/day (n=3), cindunistat 200 mg/day (n=2), and placebo (n=3); Patient Global Assessment of Arthritic Condition cindunistat 50 mg/day (n=7), cindunistat 200 mg/day (n=7), and placebo (n=4).
†Patients may be included in more than one medication class for OA Knee Pain.
BMI, body mass index; JSW, joint space width; KLG, Kellgren and Lawrence Grade; NSAID, non steroidal anti-inflammatory drug; SYSADOA, symptomatic slow acting drugs in osteoarthritis included chondroitin, glucosamine, hyaluronic acid, diacerein, and unsaponifiables of avocado and soya products; weak opioids included tramadol, codeine, and propoxyphene products; strong opioids included hydrocodone, and oxycodone products, WOMAC, Western Ontario McMaster Osteoarthritis Index.