Table 1.
Summary of clinical studies including number of subjects (observations) and mean (range) age, body weight and estimated creatinine clearance
| Study/Country | Study design | Analysis population (observation) | Age (years) | Total body weight (kg) | CLcr (ml min−1) |
|---|---|---|---|---|---|
| Healthy volunteers* | |||||
| HV01/US | R, DB, PC, XO, PK | 29 (338) | 40.1 (29, 49) | 77.4 (60, 91) | 104 (79.0, 152) |
| HV02/US | R, DB, PC, PG, PK | 45 (1409) | 35.4 (19, 50) | 75.5 (61, 94) | 108 (60.0, 155) |
| HV03/US | R, OP, XO, PK | 11 (401) | 54.2 (38, 65) | 72.2 (56, 92) | 100 (63.9, 147) |
| HV04/US | R, DB, PC, PK | 12 (393) | 31.8 (19, 48) | 75.0 (61, 85) | 120 (96.9, 147) |
| HV05/US | OP, PG, PK | 26 (327) | 56.4 (38, 75) | 80.8 (45, 106) | 57.0 (10.0, 122) |
| HV06/JP | R, SB, PC, PG, PK | 30 (422) | 22.9 (20, 28) | 62.6 (52, 83) | 113 (75.0, 163) |
| HV07/JP | R, SB, PC, PK | 6 (67) | 71.8 (67, 78) | 60.1 (46, 68) | 60.2 (54.0, 71.1) |
| HV08/JP | R, DB, PC, PG, PK | 16 (483) | 24.7 (20, 42) | 63.3 (52, 79) | 113 (91.2, 148) |
| HV09/US | R, OP, XO, PK | 20 (810) | 35.8 (21, 54) | 68.3 (55, 86) | 105 (68.9, 142) |
| Subtotal | – | 195 (4650) | 38.1 (19, 78) | 72.1 (46, 106) | 100 (10.0, 163) |
| Patients with post-herpetic neuralgia | |||||
| PT01/US | MC, R, DB, PC, PG | 92 (92) | 74.3 (48, 87) | 78.3 (48, 142) | 63.6 (35.2, 227) |
| PT02/EU, AU | MC, R, DB, PC, PG | 84 (84) | 72.8 (33, 91) | 72.9 (47, 110) | 70.6 (34.9, 123) |
| PT03/US,CA | MC, R, DB, PC, PG | 65 (101) | 73.0 (45, 101) | 74.6 (53, 102) | 70.9 (23.7, 188) |
| PT04/JP | MC, R, DB, PC, PG | 26 (50) | 73.1 (42, 87) | 54.3 (40, 70) | 66.2 (32.8,120) |
| Subtotal | – | 267 (327) | 73.4 (33, 101) | 73.4 (40. 142) | 67.8 (23.7, 227) |
| Patients with diabetic peripheral neuropathy | |||||
| PT05/JP | MC, R, DB, PC, PG | 154 (298) | 60.9 (35, 85) | 65.6 (31, 113) | 99.3 (32.2, 230) |
| All | |||||
| Total | – | 616 (5275) | 59.1 (19, 101) | 71.0 (31, 142) | 86.0 (10.0, 230) |
*
HV05 and HV07 were conducted on subjects with various degrees of renal function and on elderly subjects, respectively. US, United States; CLcr, estimated creatinine clearance; R, randomized; DB, double-blind; PC, placebo-controlled; XO, crossover; PK, pharmacokinetics; OP, open-label; PG, parallel-group; JP, Japan; SB, single-blind; MC, multicentre; EU, European countries; AU, Australia; CA; Canada.