ACTRN12615000439549已完成1 期
A Phase 1 Randomised, Double Blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Intra-articular Progenza (PRG) in Adults with Symptomatic Knee Osteoarthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Regeneus Ltd
- 入组人数
- 20
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 65 Years（—）
- 性别
- All
入选标准
- •Patients will be eligible to participate if they:
- •- are between 40 and 65 years of age inclusive
- •- have Kellgren-Lawrence grade 1, 2 or 3 symptomatic knee osteoarthritis.
- •- have moderate to severe knee pain associated with OA
排除标准
- •Patients will not be eligible to participate if they:
- •- have OA in the non-study knee that has worse pain than the study knee
- •- have had joint surgery in the past 3 years
- •- have major mechanical issues in the study knee
- •- have significant OA in other major joints
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