[Translation] A phase II, randomized, double-blind, placebo-controlled, multicenter, crossover study to evaluate the efficacy, safety, and tolerability of SR419 in patients with postherpetic neuralgia (PHN)
主要目的:
评估SR419对比安慰剂治疗PHN相关疼痛的疗效
次要目的:
1.评估SR419对比安慰剂在其他疼痛评估维度、治疗应答、患者对改变的整体印象(PGIC)、睡眠和相关功能方面的疗效
2.评估SR419在PHN患者中的安全性和耐受性
3.评估SR419在PHN患者中的药代动力学(PK)特征及其代谢物
探索性目的:
1.评估SR419治疗PHN相关疼痛的疗效与基线定量感觉测试(QST)参数之间的关系
2.评估SR419治疗PHN相关疼痛的起效时间
3.评估SR419治疗PHN相关疼痛的疗效持续时间
4.受试者对治疗效果的个体化评估
[Translation] main purpose:
To evaluate the efficacy of SR419 versus placebo in the treatment of PHN-related pain
Secondary purpose:
1. To assess the efficacy of SR419 versus placebo on other pain assessment dimensions, treatment response, patient's global impression of change (PGIC), sleep and related functions
2. To assess the safety and tolerability of SR419 in patients with PHN
3. To assess the pharmacokinetic (PK) profile of SR419 and its metabolites in PHN patients
Exploratory Purpose:
1. To assess the relationship between the efficacy of SR419 in the treatment of PHN-related pain and baseline quantitative sensory test (QST) parameters
2. To evaluate the onset time of SR419 in the treatment of PHN-related pain
3. To assess the duration of efficacy of SR419 in the treatment of PHN-related pain
4. Subject's individualized assessment of treatment effect