NCT05763550已完成2 期
A Multicenter, Randomized, Double-Blind, Double-Dummy , Pregaballin-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Herpetic Neuralgia
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 331 人开始时间: 2023年2月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 331
- 试验地点
- 1
- 主要终点
- Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4
研究概览
简要总结
Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Signed informed consent;
- •Males or females aged 18 years and older ;
- •Patients must have herpetic neuralgia;
- •At Screening, pain scale (VAS) of ≥ 40 mm;
- •At Screening, pain scale (NRS) of ≥ 4.
排除标准
- •Patients have pain present for more than 1 months after the healing of the herpes zoster skin rash;
- •AST/ALT > 2 × upper limit of normal (ULN), or TBIL≥1.5 × ULN;
- •Serum Creatine > 176μmol/L;
- •Any active infections at screening;
- •History of allergic or medically significant adverse reaction to investigational products or their excipients, pregabalin or related compounds;
- •Participated in another clinical study within 30 days prior to screening;
- •Pregnant or breastfeeding at screening ;
- •Other conditions unlikely to participate in this trial.
研究组 & 干预措施
HSK16149 20mg BID
Experimental
干预措施: HSK16149 20mg BID (Drug)
HSK16149 40mg BID
Experimental
干预措施: HSK16149 40mg BID (Drug)
Pregabalin 150mg BID
Active Comparator
干预措施: Pregabalin 150mg (Drug)
结局指标
主要结局
Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4
时间窗: Baseline and week 4
Numeric Rating Scales(NRS )was a 11-point numeric rating scale ( 0\[no pain\] to 10 \[worst possible pain\]
次要结局
- Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4(Baseline and week 4)
- Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline )(Baseline and week 4)
- Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4(Baseline and week 4)
研究者
研究点 (1)
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