ACTRN12616001429448已完成2 期
A randomised, double-blind using blinded evaluator, placebo and active controlled, pilot study to evaluate the safety and efficacy of intra articular administration of Articul One in patient with symptomatic primary knee osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 o limit（—）
- 性别
- All
入选标准
- •Provided written informed consent
- •Evidence of grade II or III OA (Kellergan-Lawrence scale) on X-ray
- •Has documented diagnosis of symptomatic primary osteoarthritis of the study knee made at least 3 months prior to Screening.
- •Has continued study knee osteoarthritis pain despite conservative treatment (e.g., weight reduction, physical therapy, analgesics).
- •Is ambulatory with an active lifestyle and in good general health.
排除标准
- •Had arthroplasty at the study knee at any time or any other previous surgery in the study knee within the 6 months prior to Screening, or planned surgery throughout the duration of the study.
- •History of septic arthritis in any joint.
- •Concomitant inflammatory disease or other condition that affects the joints.
- •Any known contraindication to paracetamol.
研究者
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