A Study to Evaluate the Efficacy and Safety of HSK16149 Capsule Combined With L-carnitine Hydrochloride Tablets and Lipoic Acid Combined With L-carnitine Hydrochloride Tablets in Diabetic Peripheral Neuralgia Patients in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- To compare the efficacy and safety of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablet and lipoic acid combined with acetyl-L-carnitine hydrochloride tablet in the treatment of diabetic peripheral neuralgia
研究概览
简要总结
Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China
详细描述
Observe the effects of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablets and lipoic acid combined with acetyl-L-carnitine hydrochloride tablets Efficacy and safety in diabetic peripheral neuralgia patients in China.
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
- None
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
- •Able to understand and voluntarily sign written informed consent;
- •Male or female over the age of 18 (including the threshold);
- •Diabetic peripheral neuralgia (DPNP) diagnosis;
- •The average pain Visual Analogue Scale (VAS) score in the past 24 h was assessed as ≥ 40 mm and < 90 mm during screening.
排除标准
- •Peripheral neuropathy or pain unrelated to DPN that the investigator determined might confuse the DPNP assessment;
- •History of malignant tumors (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary thyroid carcinoma) or history of antitumor therapy within 5 years prior to screening;
- •Severe abnormal liver and kidney function, meeting any of the following clinical laboratory test results:
- •Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN); Or total bilirubin (TBIL) > 1.5 × ULN;
- •Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (calculated according to simplified MDRD formula);
- •Known allergic history to test drug components or other drugs or excipients with similar chemical structure;
- •Past suicidal behavior or suicidal intention;
- •Women who are pregnant, planning to become pregnant during the study period, or breastfeeding; Women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or Iuds) for 28 days after signing up for the ICF from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period;
- •Participated in any other clinical studies within 30 days prior to screening;
- •The researcher determines that there are other conditions that are not suitable for participation in this study.
研究组 & 干预措施
HSK16149 capsule combined with L-carnitine hydrochloride
HSK16149 capsule (20 mg/ capsule) was administered orally, 1 capsule twice a day for 12 weeks. Acetyl-l-carnitine hydrochloride tablets (0.25g/ tablet) were administered orally after meals, 2 tablets 3 times a day for 12 weeks
干预措施: HSK16149 20mg BID (Drug)
Lipoic acid combined with L-carnitine hydrochloride
HSK16149 capsule (20 mg/ capsule) was administered orally, 1 capsule twice a day for 12 weeks. Lipoic acid tablets (0.3g/ tablet) were administered half an hour before breakfast, 2 tablets once a day for 11 weeks.
干预措施: HSK16149 20mg BID (Drug)
结局指标
主要结局
To compare the efficacy and safety of HSK16149 capsule combined with acetyl-L-carnitine hydrochloride tablet and lipoic acid combined with acetyl-L-carnitine hydrochloride tablet in the treatment of diabetic peripheral neuralgia
时间窗: week12
Using the Analysis of Covariance (ANCOVA) model, changes in ADPS relative to baseline at 12 weeks of treatment were taken as dependent variables, and baseline values of study centers, groups, and ADPS were taken as explanatory variables, and the adjusted least squares mean and standard errors of each group were listed. The difference and 95% confidence interval of the mean change of ADPS from baseline at 12 weeks in the HSK16149 capsule combined with acetyl-L-carnitine hydrochloride group compared with the lipoic acid combined with acetyl-L-carnitine hydrochloride group were calculated.
次要结局
未报告次要终点