NCT06490484招募中2 期
Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain Who Had an Inadequate Response to Pregabalin: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Pregabalin-controlled Phase 2 Study
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月19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
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Compare the change from baseline in Visual Analog Scale (VAS) between HSK16149 and Pregabalin at week 4.
研究概览
简要总结
Investigate the efficacy and safety of HSK16149 capsule in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) who had an inadequate response to Pregabalin, 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 ≤ 11.0% at screening and on a stable anti-diabetic medication regimen for at least 30 days prior to screening;
- •Have a visual analog scale (VAS) pain value ≥60 mm in the past 24 h during screening;
- •DPNP patients are currently receiving continuous treatment with pregabalin for more than 4 weeks who had an inadequate response.
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;
- •AST/ALT > 2.5 × upper limit of normal (ULN), or TBIL > 1.5 × ULN;
- •Estimation of glomerular filtration rate (eGFR) < 60 mL/min / 1.73 m^2;
- •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.
- •History of allergic or medically significant adverse reaction to investigational products or their excipients, duloxetine 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.
- •The investigators determine that there are other conditions that are not suitable for participation in this study.
研究组 & 干预措施
Pregabalin 150 BID
Experimental
Drug: Pregabalin 150mg BID Pregabalin 150mg, orally twice a day; treatment period: 1 week titration and 3 weeks fixed dose.
干预措施: Pregabalin 150mg BID (Drug)
HSK16149 20mg BID
Experimental
Drug: HSK16149 20mg BID HSK16149 20mg, orally twice a day; treatment period: 4 weeks fixed dose.
干预措施: HSK16149 20mg BID (Drug)
结局指标
主要结局
Compare the change from baseline in Visual Analog Scale (VAS) between HSK16149 and Pregabalin at week 4.
时间窗: Baseline and week 4
The VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.
次要结局
- Compare the change from baseline in Numeric Rating Scales (NRS) between HSK16149 and Pregabalin at week 4.(Baseline and week 4)
- Compare the change from baseline in Visual Analog Scale (VAS) between HSK16149 and Pregabalin at treatment period.(Baseline to week 4)
- Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) betwwen HSK16149 and Pregabalin at week 4.(Baseline and week 4)
- Compare the change from baseline in Daily Sleep Interference Score (DSIS) between HSK16149 and Pregabalin at week 4.(Baseline and week 4)
- Compare the change from baseline in EuroQol-5-Domain-5-Level health questionnaire (EQ-5D-5L) between HSK16149 and Pregabalin at week 4.(Baseline and week 4)
研究者
研究点 (1)
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