NCT04647773Unknown2 期
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Pregabalin Capsule-Controlled, 13-Week, Adaptive-design Phase 2/3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 687 人开始时间: 2020年12月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 687
- 试验地点
- 1
- 主要终点
- Compare the change from baseline in Average Daily Pain Score（ADPS） between HSK16149 and placebo at week 5.
研究概览
简要总结
Investigate the efficacy and safety of HSK16149 capsules in Chinese diabetic peripheral neuropathic pain (DPNP) following 13 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;
- •Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;
- •HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening;
- •At Screening, pain scale (VAS) of ≥40 mm and <90 mm.
排除标准
- •Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP.
- •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:
- •Neutrophils < 1.5 × 10^9/L, or platelet < 90 × 10^9/L, or hemoglobin < 100 g/L, or
- •AST/ALT > 2.5 × upper limit of normal (ULN), or TBIL > 1.5 × ULN, or
- •Estimation of glomerular filtration rate (eGFR) < 60 mL/min / 1.73 m^2, or
- •Creatine kinase > 2.0 × ULN.
- •History of substance abuse or alcohol abuse.
- •Acute complications of diabetes in the 6 months prior to screening.
- •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).
- •Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of DPNP.
- •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.
- •Participated in another clinical study within 30 days prior to screening.
- •Other conditions of the subjects who are unlikely to comply with the protocol.
- •Could potentially affect a subject's safety.
研究组 & 干预措施
HSK16149 40mg BID
Experimental
干预措施: HSK16149 40mg BID (Drug)
HSK16149 20mg BID
Experimental
干预措施: HSK16149 20mg BID (Drug)
Pregabalin 150mg BID
Active Comparator
干预措施: Pregabalin 150mg BID (Drug)
HSK16149 60mg BID
Experimental
干预措施: HSK16149 60mg BID (Drug)
HSK16149 80mg BID
Experimental
干预措施: HSK16149 80mg BID (Drug)
Placebo BID
Placebo Comparator
干预措施: Placebo BID (Drug)
结局指标
主要结局
Compare the change from baseline in Average Daily Pain Score（ADPS） between HSK16149 and placebo at week 5.
时间窗: Baseline and week 5
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.
Compare the change from baseline in Average Daily Pain Score （ADPS） between HSK16149 and placebo at week 13.
时间窗: Baseline and week 13
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
- AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 in 5 weeks post treatment.(From week 1 to week 5)
- Compare the response rate between HSK16149 and placebo at week 5 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).(Baseline and week 5)
- Compare the response rate between HSK16149 and placebo at week 13 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline ).(Baseline and week 13)
- Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 13.(From week 1 to week 13)
- Compare the change from baseline in Visual Analog Scale （VAS） between HSK16149 and placebo at week 13.(Baseline and week 13)
- Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 13.(Baseline and week 13)
- Compare the Patient Global Impression of Change（PGIC） between HSK16149 and placebo at week 13.(Week 13)
- Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HSK16149 and placebo at week 13.(Baseline and week 13)
- Compare the change from baseline in EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L) between HSK16149 and placebo at week 13.(Baseline and week 13)
- AE, laboratory tests, physical and neurological examination, vital signs and 12-lead ECG to evaluate the safety of HSK16149 during the trial.(From week 1 to week 14)
- Pharmacokinetic (PK) characteristics of HSK16149 capsules in Chinese patients with diabetic peripheral neuropathic pain.(Week 1,week 5,week 11,week 13)
研究者
研究点 (1)
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