A Multi-center, Randomized, Double-blind, Placebo Controlled Trial of SUPARTZ (Sodium Hyaluronate) for the Treatment of Chronic Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Visual Analogue Scale (VAS: 0-100) for Pain on Movement
研究概览
简要总结
This clinical trial is to determine the safety and effectiveness of three injections of SUPARTZ (sodium hyaluronate) compared with phosphate buffered saline (PBS) for the treatment of glenohumeral osteoarthritis of the shoulder. The trial contains two phases. Phase I is 26 weeks, double blinded, and subjects are randomized to either SUPARTZ or PBS treatment. Phase II is 26 weeks (total 52 weeks) and open-label so all subjects will receive SUPARTZ injections only.
详细描述
Phase 3 Study: Multi-center, randomized, double blinded, two phase study to determine the safety and efficacy of 3 injections of SUPARTZ for Osteoarthritis of the Shoulder
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glenohumeral Osteoarthritis (OA) confirmed by radiograph
- •Limitation of shoulder motion in at least one direction
- •Retained active range of motion of at least 30% in all directions
排除标准
- •Full thickness rotator cuff tear or rotator cuff tendinopathy
- •Frozen shoulder
- •Female who is pregnant or lactating
结局指标
主要结局
Visual Analogue Scale (VAS: 0-100) for Pain on Movement
时间窗: Ph1: weeks 7 - 26
Visual Analogue Scale (VAS) for pain on (shoulder) movement with a range of 0 to100; where 0=No pain at all and 100=Pain as bad as it can be. Q: How bad is the pain in your study shoulder with activity or movement? (For example, when putting on a coat, sleeping on your study shoulder side, combing your hair, reaching a high shelf, etc.) Reported is a single Least square mean point estimate over the 7-26 week time interval using the assessments collected at weeks 7, 13, 20, and 26
次要结局
未报告次要终点