Table 1

Baseline demographics and clinical characteristics for all randomised patients

Cindunistat
50 mg/day200 mg/dayPlacebo
N=485N=486N=486
Age (years)
 Mean±SD61.0±8.760.8±8.661.3±9.1
 Range40–8540–8740–89
Gender
 Female383 (79.0)367 (75.5)364 (74.9)
 Male102 (21.0)119 (24.5)122 (25.1)
Race
 White389 (80.2)410 (84.4)405 (83.3)
 Other96 (19.8)76 (15.6)81 (16.7)
BMI (kg/m2)
 Mean±SD31.9±4.132.0±4.131.6±4.1
 Range24.4–40.323.7–40.124.6–40.5
Region
 N. America/Australia286 (59.0)262 (53.9)273 (56.2)
 Europe142 (29.3)166 (34.2)152 (31.3)
 S. America57 (11.8)58 (11.9)61 (12.6)
Time since diagnosis (years)
 Mean±SD6.4±6.36.7±7.26.8±7.2
 Range0.1–43.90.0–44.00.0–62.0
KLG
 KLG≤2216 (44.5)203 (41.8)222 (45.7)
 KLG3269 (55.5)283 (58.2)264 (54.3)
JSW (mm)*
 Mean±SD3.17±0.753.20±0.743.22±0.71
 Range1.56–5.411.55–5.981.43–5.28
WOMAC pain* (range 0–20)
 Mean±SD8.0±3.97.4±3.97.6±4.0
WOMAC physical function* (range 0–68)
 Mean±SD27.6±13.926.5±13.227.4±13.8
Patient global assessment of arthritic condition* (range 0–100)
40.2±24.837.6±24.339.4±23.9
Concomitant analgesics†
 NSAIDs/Coxibs/aspirin301 (62.1)292 (60.1)306 (63.0)
 Acetaminophen100 (20.6)97 (20.0)94 (19.3)
 SYSADOA41 (8.5)36 (7.4)40 (8.2)
 Weak opioids32 (6.6)15 (3.1)22 (4.5)
 Strong opioids4 (0.8)5 (1.0)3 (0.6)
 Glucocorticoids1 (0.2)0 (0)1 (0.2)
 None109 (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.