Table 4.
TTX Dosage | |||||
---|---|---|---|---|---|
7.5 µg BID N = 25 |
15 µg BID N = 24 |
30 µg QD N = 25 |
30 µg BID N = 26 |
Placebo N = 25 |
|
Time to Peak Pain Relief a | |||||
n | 23 | 24 | 23 | 25 | 25 |
Mean change (Weeks) (±SD) |
2.5 (±1.2) | 2.4 (±1.2) | 3.0 (±1.2) | 2.6 (±1.3) | 2.5 (±1.1) |
Kaplan–Meier Estimate of weeks to peak pain relief | |||||
Median (Weeks) (95% CI) |
3.00 (1.00, 3.00) |
2.50 (1.00, 3.00) |
3.00 (3.00, 4.00) |
3.00 (1.00, 4.00) |
3.00 (1.00, 3.00) |
CI: confidence interval; NPRS: Numerical Pain Rating Scale; SD: standard deviation; TTX: tetrodotoxin; BID: twice daily; QD: once daily; n: number of subjects. Note: Time to peak pain relief defined as the time from first dose of study medication to the date of the maximum pain relief. Week 1 = Days 1 to 7, Week 2 = Days 8 to 14, Week 3 = Days 15 to 21, Week 4 = Days 22 to 28. a Subjects who withdrew from the study early or subjects who completed the study but took rescue on their last visit were censored at their last visit with the last non-missing average pain score.