Table 1 Subjects characteristics at baseline
Double-blind trial | Open-label trial (N = 63) | |||
|---|---|---|---|---|
Pregabalin (N = 54) | Placebo (N = 53) | Total (N = 107) | ||
Hormonal status of female patients, n | ||||
48 | 44 | 92 | 53 | |
Premenarchal, n (%) | 1 (2.1) | 1 (2.3) | 2 (2.2) | 2 (3.8) |
Menarche, n (%) | 47 (97.9) | 43 (97.7) | 90 (97.8) | 51 (96.2) |
Age, years | ||||
Mean (SD) | 14.6 (1.2) | 14.7 (1.2) | 14.7 (1.2) | 14.8 (1.4) |
Range | 12–17 | 12–16 | 12–17 | 12–17 |
Age, years, n (%) | ||||
12 | 4 (7.4) | 3 (5.7) | 7 (6.5) | 4 (6.3) |
13 | 5 (9.3) | 6 (11.3) | 11 (10.3) | 8 (12.7) |
14 | 15 (27.8) | 8 (15.1) | 23 (21.5) | 10 (15.9) |
15 | 18 (33.3) | 21 (39.6) | 39 (36.4) | 19 (30.2) |
16 | 10 (18.5) | 15 (28.3) | 25 (23.4) | 16 (25.4) |
17a | 2 (3.7) | 0 | 2 (1.9) | 6 (9.5) |
Race, n (%) | ||||
White | 29 (53.7) | 32 (60.4) | 61 (57.0) | 35 (55.6) |
Asian | 21 (38.9) | 15 (28.3) | 36 (33.6) | 20 (31.7) |
Black | 2 (3.7) | 3 (5.7) | 5 (4.7) | 4 (6.3) |
Other | 2 (3.7) | 3 (5.7) | 5 (4.7) | 4 (6.3) |
Weight, kg | ||||
Mean (SD) | 60.4 (21.4) | 59.7 (17.7) | 60.1 (19.6) | 61.6 (18.5) |
Range | 28.5–154.7 | 39.0–127.6 | 28.5–154.7 | 29.8–135.5 |
Height, cm | ||||
Mean (SD) | 160.1 (7.6) | 162.3 (8.2) | 161.2 (7.9) | 161.8 (8.3) |
Range | 141.0–177.8 | 147.0–183.0 | 141.0–183.0 | 141.0–184.0 |
Duration of FM symptoms, years | ||||
Mean (median) | 1.7 (1.1) | 2.1 (1.4) | 1.9 (1.3) | 0.8 (0.5) |
Range | 0.3–11.1 | 0.4–11.7 | 0.3–11.7 | 0.33.9 |