NCT02705625已完成2 期
A Randomised, Double-blind Placebo-controlled Phase IIa Study to Evaluate Efficacy, Safety and Tolerability of MIV-711 in Knee Joint Osteoarthritis
Medivir5 个研究点 分布在 5 个国家目标入组 244 人开始时间: 2016年1月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 5
- 主要终点
- Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26
研究概览
简要总结
This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel, Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with knee osteoarthritis (OA).
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current average knee pain, defined as pain in either knee, within 1 week before visit 1, for which the patient gives a severity score of ≥4, <10 on a 0-10 NRS (Numeric Rating Scale).
- •Inclusive of 40-80 years old.
- •Diagnosis of primary knee osteoarthritis
排除标准
- •The presence of any inflammatory arthritis
- •Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
- •Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
- •Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
研究组 & 干预措施
MIV-711:1
Experimental
MIV-711 for a total of 26 w
干预措施: MIV-711 (Drug)
MIV-711:2
Experimental
MIV-711 for a total of 26 w
干预措施: MIV-711 (Drug)
Placebo
Placebo Comparator
Placebo for a total of 26 w
干预措施: Placebo (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26
时间窗: baseline and 26 weeks
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in NRS average target knee pain score. NRS (Numeric rating scale) ranges from 0 indicating -"no pain", to 10 indicating - "pain as bad as it could be".
次要结局
- Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26(baseline and 26 weeks)
- Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26(baseline and 26 weeks)
- Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score(baseline and 26 weeks)
- Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score(baseline and 26 weeks)
- Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score(baseline and 26 weeks)
- Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26(baseline and 26 weeks)
- Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26(baseline and 26 weeks)
研究者
研究点 (5)
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