Table 1.
Summary of neuropathic pain studies included in the analysis
| Condition (study number/ClinicalTrials.gov identifier) | Total treatment phase/maintenance phase (weeks) | Pregabalin maintenance dose (mg/day) | Administration | No. of participantsa | ||
|---|---|---|---|---|---|---|
| Placebo | Pregabalin | Total | ||||
| PHN (A0081120/NCT00394901)30,34 | 13/12 | 150, 300, 600b | BID fixed dose | 97 | 272 | 369 |
| DPN (A0081163/NCT00553475)22,30 | 13/12 | 300, 600b | BID fixed dose | 135 | 179 | 314 |
| SCI (A0081107/NCT00407745)24 | 16/12 | 150–600 | BID flexible dose | 27 | 32 | 59 |
Notes:
a
Efficacy analyses were performed on all randomized subjects with baseline mean pain score ≥4 who had received at least one dose of study medication, with at least one post-baseline entry in the daily pain diary for each trial. Efficacy analysis for the SCI trial was based on the Japanese subpopulation.
b
All trials included a matching placebo treatment arm.
Abbreviations: BID, twice-daily; DPN, diabetic peripheral neuropathy; PHN, post-herpetic neuralgia; SCI, spinal cord injury.