NCT05140863已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week, Phase 3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Postherpetic Neuralgia
Haisco Pharmaceutical Group Co., Ltd.2 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- Compare the change from baseline in ADPS between HSK16149 and placebo at week 12
研究概览
简要总结
Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia Following 12 Weeks Treatment in Comparison to Placebo
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 75 Years（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 18-75 years of age inclusive;
- •Outpatient, Patients can not stay in the hospital overnight;
- •Patients must have pain present for more than 1 months after the healing of the herpes zoster skin rash;
- •At Screening, pain scale (VAS) of ≥40 mm;
排除标准
- •Peripheral neuropathy or pain unrelated to PHN that may confuse the assessment of PHN;
- •Skin conditions in the area affected by neurupathy that could alter sensation;
- •Chronic systemic diseases that may affect subjects' participation in the study;
- •Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:1)Neutrophils < 1.5 × 109/L, or platelet < 90 × 109/L, or hemoglobin < 100 g/L, or 2)AST/ALT > 2.5 × upper limit of normal (ULN), or TBIL > 1.5 × ULN, or 3)Estimation of glomerular filtration rate (eGFR) < 60 mL/min / 1.73 m2, or 4)Creatine kinase > 2.0 × ULN.
- •Uncontrolled diabetes(HbA1c≥11.0% at screening) ;
- •History of substance abuse or alcohol abuse;
- •Any active infections at screening;
- •HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive;
- •Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3);
- •Patients who have undergone neurolytic or neurosurgical therapy 1 week before screening for postherpetic neuralgia;
- •Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of PHN;
- •History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds;
- •History of suicidal behavior or attempted suicide;
- •Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period;
- •Mechanical operators who are engaged in high-altitude operations, motor vehicle driving and other dangerous machinery operators;
- •Participated in another clinical study within 30 days prior to screening;
- •Other conditions unlikely to participate in this trial.
研究组 & 干预措施
HSK16149 20mg BID
Experimental
HSK16149 20mg, orally twice a day for 12 weeks
干预措施: HSK16149 20mg BID (Drug)
HSK16149 40mg BID
Experimental
HSK16149 40mg, orally twice a day for 12 weeks
干预措施: HSK16149 40mg BID (Drug)
Placebo BID
Placebo Comparator
placebo, orally twice a day for 12 weeks
干预措施: Placebo BID (Drug)
结局指标
主要结局
Compare the change from baseline in ADPS between HSK16149 and placebo at week 12
时间窗: Baseline and week 12
The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 \[no pain\] to 10 \[worst possible pain\]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries
次要结局
- Compare the change from baseline in Visual Analogue Scale（VAS） between HSK16149 and placebo at week 12(Baseline and week 12)
- Compare the change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 12(Baseline and week 12)
- Compare the change from baseline in Average Daily Sleep interference score（ADSIS） between HSK16149 and placebo at week 12(Baseline and week 12)
- Area under the plasma concentration versus time curve (AUC) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia(Week 4,week 8,week 10,week 12)
- Compare the response rate between HSK16149 and placebo at week 12 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline )(Baseline and week 12)
- Compare the total consumption of Acetaminophen and Paracetamol and Dihydrocodeine Tartrate between HSK16149 and placebo during the trial(From week 1 to week 12)
- Compare the change from baseline in EQ-5D-5L between HSK16149 and placebo at week 12(Baseline and week 12)
- Peak Plasma Concentration (Cmax) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia(Week 4,week 8,week 10,week 12)
- Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 12(From week 1 to week 12)
- AE（adverse event） to evaluate the safety of HSK16149 during the trial(From week 1 to week 12)
研究者
研究点 (2)
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