Evaluation of the Structure-modifying Effect and Safety of Avocado-Soybean Unsaponifiable (Piascledine 300) in Hip Osteoarthritis (OA) a 3 Years Multicenter Randomized, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- The main criterion of efficacy is the change of JSW between baseline and end point. JSW is measured on the narrowest joint on pelvic or target hip X ray by blinded reader.
研究概览
简要总结
This study aims to assess the long term (three years) ability of ASU (Avocado Soya unsaponifiable) to slow the decrease of radiographic JSW (Joint Space Width) in hip osteoarthritis (OA). This is a randomized, double blind, comparative, parallel group study versus placebo.
详细描述
Inclusion criteria:
Primary hip OA, fulfilling ACR criteria, patient over 45 y, painful > 1 year, Lequesne's index > or equal to 3, with minimum JSW at the target hip > 1 mm and < 4 mm on pelvic radiograph.
Primary criterion of efficacy:
The main criterion of efficacy is the change of JSW between baseline and end point. JSW is measured on the narrowest joint on pelvic or target hip X ray by blinded reader.
Randomisation is stratified according JSW at baseline (< 2,5 mm or > or equal to 2,5 mm).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary OA of hip,
- •ACR criteria,
- •older than 45 years,
- •symptomatic painful > 1 an,
- •Lequesne's index > or equal to 3,
- •JSW between 1 and 4 mm on pelvic radiograph.
排除标准
- •secondary OA.
研究组 & 干预措施
ASU (Avocado Soybean Unsaponifiable)
干预措施: ASU (Drug)
结局指标
主要结局
The main criterion of efficacy is the change of JSW between baseline and end point. JSW is measured on the narrowest joint on pelvic or target hip X ray by blinded reader.
次要结局
未报告次要终点