安慰剂
医学
普瑞巴林
麻醉
钠通道阻滞剂
随机对照试验
置信区间
安慰剂对照研究
周围神经病变
内科学
双盲
糖尿病
化学
替代医学
钠
有机化学
病理
内分泌学
钠通道
作者
Aoibhinn McDonnell,Susie M. Collins,Zahid Ali,Laura Iavarone,Raulin Surujbally,Simon Kirby,Richard P. Butt
出处
期刊:Pain
[Ovid Technologies (Wolters Kluwer)]
日期:2018-03-23
卷期号:159 (8): 1465-1476
被引量:110
标识
DOI:10.1097/j.pain.0000000000001227
摘要
Abstract The effect of PF-05089771, a selective, peripherally restricted Na v 1.7 sodium channel blocker on pain due to diabetic peripheral neuropathy was investigated in a randomised, placebo and active-controlled parallel group clinical trial (NCT02215252). A 1-week placebo-run in the period was followed by a 4-week treatment period and a 1-week placebo run-out/taper-down period. Single-blind placebo was administered throughout run-in and run-out periods. Subjects were randomised to receive either PF-05089771 150 mg twice daily, pregabalin 150 mg twice daily, or placebo during the 4-week treatment period. One hundred thirty-five subjects were randomised. The primary endpoint was the average pain score derived from subjects' Numerical Rating Scale scores over the past 7 days of week 4 of the double-blind treatment period. Predefined efficacy criteria for the trial were the effect of PF-05089771 being >0.5 units better than placebo at interim analysis after completion of the first part of the study. Although a trend for a reduction in the weekly average pain score in the PF-05089771 treatment group was observed, this was not statistically significant when compared with placebo at week 4, with a mean posterior difference of −0.41 (90% credible interval: −1.00 to 0.17). The effect of PF-05089771 was smaller than that seen with pregabalin, which was statistically significant when compared with placebo at week 4, with a mean posterior difference of −0.53 (90% credible interval: −0.91 to −0.20). As predefined efficacy criteria were not met, the study did not proceed to the second part. PF-05089771 was well tolerated. Possible reasons for the modest efficacy observed with PF-05089771 are discussed.
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