A 52-week, Open Phase III Study Evaluating the Long-term Safety and Efficacy of HSK16149 Capsules in Chinese Patients With Peripheral Neuralgia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 301
- 试验地点
- 24
- 主要终点
- To evaluate the long-term safety of HSK16149 capsules in Chinese patients with peripheral neuralgia.
研究概览
简要总结
Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with periphcral neuralgia
详细描述
Investigate the long-term(52 weeks) safety and efficacy of HSK16149 capsules in Chinese patients with Peripheral neuropathic pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects who completed double-blind treatment and safety follow-up in HSK16149-201/
- •Able to understand and voluntarily sign informed consent.
排除标准
- •Medication compliance was < 80% in double-blind studies.
- •In double-blind study, EOT visit (V10) eGFR< 60 mL/min//1.73m2
- •Significant safety concerns or adverse events that did not recover before taking the drug in this study arose in the double-blind study.
- •Hepatitis B Surface antigen (HBsAg) positive or hepatitis C virus antibody (HCV Ab) positive during screening [further hepatitis B virus deoxyribonucleic acid (HBV DNA) titer detection or hepatitis C virus ribonucleic acid (HCV RNA) detection (beyond the detection limit of assay need to be excluded)], human immunodeficiency virus antibody (HIV) Ab) positive, serum antibody to treponema pallidum (TP Ab) positive (further test for treponema pallidum titer, if positive, excluded).
- •Women who are pregnant, planning to become pregnant during the study, or breastfeeding; Participants were not expected to use reliable contraceptive methods (including condoms, spermicides, or intrauterine devices) for 28 days after signing up for the ICF or planning to use progester-containing contraceptives during this period.
- •The researcher judged that the study could not be completed according to the scheme or that it was difficult to participate in the study due to safety.
研究组 & 干预措施
HSK16149 40mg BID
HSK16149 40mg , orally twice a day, treatment period; 52-weeks fixed dose.
干预措施: HSK16149 40mg BID (Drug)
结局指标
主要结局
To evaluate the long-term safety of HSK16149 capsules in Chinese patients with peripheral neuralgia.
时间窗: From week 1 to week 53
Safety assessment variables included AE, ECG, laboratory test values, height and weight, physical examination, and vital signs. Safety data will be summarized by aggregate in SS and all subjects will be listed. Overall description of all AE occurred in subjects by total, and summary of cases, cases and percentage. Clinical judgments of laboratory indicators before and after drug administration (according to the range of normal values or the investigator's judgment of clinical significance) were summarized in the form of crosstabs, and the number and percentage of cases were calculated.
次要结局
- Changes in SF-MPQ scores from baseline before and after treatment to evaluate the long-term effectiveness of HSK16149.(From week 1 to week 53)