A Randomized, Placebo-controlled Study to Explore Safety, Dose and Efficacy of NBMI in a Mercury Intoxicated Population
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Mercury Intoxication Medical Score Sum
研究概览
简要总结
A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of mercury intoxication.
详细描述
The objectives of this study are to evaluate the efficacy and safety of two doses of NBMI compared to placebo in mercury intoxicated patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NBMI (Emeramide) 100mg
NBMI oral capsules 100mg administered once daily. Double dummy used for blinding i.e. 2 x 50mg NBMI + 1 x 200mg placebo capsule equals in total 3 capsules administered daily.
干预措施: Emeramide (Drug)
NBMI (Emeramide) 300mg
NBMI oral capsules 300mg administered once daily. Double dummy used for blinding i.e. 2 x 50mg NBMI + 1 x 200mg NBMI capsule equals in total 3 capsules administered daily.
干预措施: Emeramide (Drug)
Placebo
Placebo oral capsules administered once daily. Double dummy used for blinding i.e. 2 x 50mg size + 1 x 200mg size placebo capsules equal in total 3 capsules administered daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Mercury Intoxication Medical Score Sum
时间窗: 45 days
Changes from baseline in mercury intoxication medical score sum compared between treatment arms.
次要结局
- Blood mercury levels(45 days)
- Adverse events(45 days)
- Vital signs(45 days)
- Fatigue score(15 days)
- NBMI urine levels(14 days)
- Neuromotoric functions(45 days)
- NBMI blood levels(14 days)
- Safety laboratory assessments(45 days)
- Individual components of Mercury Intoxication Medical Score Sum(45 days)
- Urine mercury levels(45 days)