Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 395
- 试验地点
- 23
- 主要终点
- Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment
研究概览
简要总结
Matrix metalloproteinases (MMPs) have been implicated in the cartilage degradation. PG-530742 inhibits some MMPs, potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.
详细描述
Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate knee osteoarthritis confirmed by a radiographic technique.
排除标准
- •secondary knee osteoarthritis;
- •diseases other than osteoarthritis that could cause knee pain;
- •any disease or intervention (surgery, intra-articular injection) that would have an impact on knee pain or mobility;
- •drugs that act potentially on the bone or cartilage component of the knee joint.
研究组 & 干预措施
Placebo
Placebo tablet
干预措施: Placebo (Drug)
25 mg PG-530742
25 mg PG-530742
干预措施: PG-530742 (Drug)
50 mg PG-530742
50 mg PG-530742
干预措施: 50 mg PG-530742 (Drug)
100 mg PG-530742
100 mg PG-530742
干预措施: 100 mg PG-530742 (Drug)
200 mg PG-530742
200 mg PG-530742
干预措施: 200 mg PG-530742 (Drug)
结局指标
主要结局
Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment
时间窗: baseline and 12 months
The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year
时间窗: baseline and 12 months
The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)
次要结局
未报告次要终点