A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Assess the Efficacy, Safety, and Tolerability of SR419 in Patients With Postherpetic Neuralgia (PHN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 13
- 主要终点
- Daily Average Pain Score (DAPS)
研究概览
简要总结
This is a Phase II, international multicenter, double-blind, placebo-controlled, crossover study to assess the efficacy of SR419 in PHN subjects.
详细描述
The study will evaluate the efficacy and safety of SR419 in PHN patients. Each subject will participate in the study for up to approximately 14 weeks. This includes a screening period, drug treatment period, and post-treatment safety follow-up period. This is a crossover design study, in which subjects will be administered with SR419 and placebo according to their randomized sequence, that is, eligible subjects will be randomized in a 1:1 ratio to 1 of 2 double-blind treatment sequences: 30 mg of SR419 administered TID followed by placebo administered TID or placebo administered TID followed by 30 mg of SR419 administered TID.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female over 18 years old;
- •Having neuropathic pain of postherpetic neuralgia (PHN) that persists for >3 months after the herpes zoster rash is healed, with the pain area of a continuous area of affected rash.
- •DN4 score is ≥4 at Screening;
- •Average PI-NRS score of PHN-associated neuropathic pain over the last 24 hours at Screening is ≥4 and ≤9;
- •Female subjects must be non-pregnant and non-lactating;
排除标准
- •Other pains that cannot be clearly differentiated from PHN and may interfere with PHN assessment;
- •Circumstances that may affect pain assessment as determined by the investigator, such as skin disorders in the affected skin area that may affect sensation;
- •Active herpes zoster infection at screening;
- •Serious acute or chronic medical condition that, as assessed by the investigator, could increase the risks in subjects for participating in the trial or taking the study drug, or interfere with the study results;
- •Previous administration of other study drugs within 30 days or 5 half-lives before the study intervention used in this study (whichever is longer).
研究组 & 干预措施
SR419-Placebo sequence
30 mg of SR419 administered TID for 4 weeks followed by placebo administered TID for 4 weeks
干预措施: SR419 (Drug)
Placebo-SR419 sequence
placebo administered TID for 4 weeks followed by 30 mg of SR419 administered TID for 4 weeks
干预措施: SR419 (Drug)
结局指标
主要结局
Daily Average Pain Score (DAPS)
时间窗: up to Day 64
To assess the difference between the two treatment periods in the weekly average of Daily Average Pain Score (DAPS) at the last week. The pain intensity numerical rating scale (PI-NRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
次要结局
- Daily Sleep Interference Score(up to Day 64)
- Adverse events(up to Day 70)
- Patient Global Impression of Change (PGIC)(up to Day 64)