NCT00790998已完成3 期
A Single-Dose, Ivermectin-Controlled, Double-Blind, Efficacy, Safety And Tolerability Study Of Orally Administered Moxidectin In Subjects Infected With Onchocerca Volvulus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,497
- 试验地点
- 4
- 主要终点
- skin microfilaria density (mf/mg)
研究概览
简要总结
This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with Onchocerca volvulus infection
排除标准
- •Pregnant or breast feeding women; coincidental loiasis
研究组 & 干预措施
Moxidectin
Experimental
Moxidectin 8mg
干预措施: Moxidectin (Drug)
Ivermectin
Active Comparator
Ivermectin 150 mcg/kg
干预措施: Ivermectin (Drug)
结局指标
主要结局
skin microfilaria density (mf/mg)
时间窗: 12 months
次要结局
- skin microfilaria density (mf/mg)(18 months)
- skin microfilaria reduction from baseline(18 months)
- proportion of subjects with undetectable levels of skin microfilaria(18 months)
- percent reduction in microfilaria levels in the anterior chamber of the eye(12 months)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant AlbendazoleOnchocerciasisNCT04311671Medicines Development for Global Health12,979
进行中（未招募）
3 期
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for OnchocerciasisOnchocerciasisNCT03876262Medicines Development for Global Health323
已完成
2 期
Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus InfectionOnchocerciasisNCT00300768Medicines Development for Global Health172
已完成
3 期
Moxidectin for LF, Cote d'Ivoire (DOLF)Lymphatic FilariasisNCT04410406Washington University School of Medicine164
已完成
3 期
Efficacy and Safety of MOX/ALB Co-administrationTrichuriasisHookworm InfectionsAscariasisNCT04726969Jennifer Keiser255