NCT07731685尚未招募1 期
A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of VC004 Capsules for Pain in Bone Metastases
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change from baseline in the daily average pain intensity Numeric Rating Scale (NRS) score
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Phase Ib study evaluating the safety and efficacy of VC004 capsules for the relief of moderate-to-severe pain associated with bone metastases
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must understand and voluntarily sign the informed consent form (ICF);
- •Male or female, aged ≥ 18 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- •Life expectancy of ≥ 12 weeks, as assessed by the investigator;
- •The participant is able to communicate well with the investigator, and is willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •The participant's pain is associated with oncologic emergencies, such as intestinal obstruction/perforation, spinal cord compression, epidural metastasis, or fracture or impending fracture of weight-bearing bones;
- •The participant has known or suspected unstable brain metastases or leptomeningeal metastases；
- •History of severe alcohol, analgesic, or narcotic drug abuse within 6 months prior to screening;
- •Major surgery within 3 months prior to screening, or planned major surgery during the study period;
- •Female participants who are planning to become pregnant, are pregnant, or are breastfeeding; or participants who are unwilling or unable to use effective contraception throughout the entire study period and for 3 months after the end of the study;
- •Any other condition that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.
结局指标
主要结局
Change from baseline in the daily average pain intensity Numeric Rating Scale (NRS) score
时间窗: At Week 1, Week 2 and Week 4
次要结局
未报告次要终点
研究者
研究点 (1)
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