NCT00969501已完成不适用
Investigator Initiated, Exploratory Case Study Three Injections of EUFLEXXA (Sodium Hyaluronate)Treatment of Chronic Shoulder Pain Associated With Osteoarthritis
Georgia Institute for Clinical Research, LLC1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With a Reduction in Pain by the Scores.
研究概览
简要总结
The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an improvement in pain levels and range of motion.
详细描述
To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be age 30 to 79
- •Give written informed consent for trial participation
- •Must have shoulder pain for a minimum of 6 months but less than 5 years
- •Must have a Pain Intensity Score of > 5
- •Must be willing to discontinue all pain medications 24 hours prior to each clinic visit
- •Must have a stable pain medication regime 1 month prior to treatment
- •Agrees to maintain pain medication doses within 30% (increase or decrease) of the Baseline dose
排除标准
- •Any history of full thickness rotator cuff tear or joint effusion
- •A diagnosis of chronic acromioclavical disease, active epicondylitis, or active Carpal Tunnel Disease
- •Has had more than 2 corticosteroid injections in the previous 3 months
- •Has an infection or an inflammatory condition of the trial shoulder
- •Has acute or inflammatory arthropathy in the trial shoulder, e.g. gouty arthritis, psoriatic arthritis or rheumatoid arthritis. Has a history of systemic inflammatory arthropathies, e.g. polyarthritis, rheumatoid arthritis, psoriatic arthritis or gout
- •Has severe joint effusion of the trial shoulder
- •Has a diagnosis of cancer within the past 5 years (basal cell carcinoma is not excluded)
- •Has had any hyaluronate agent or other chondroprotective agents in the trial shoulder
- •Has a hypersensitivity to HA products, eggs, birds or feathers
- •Has a history of substance abuse, alcohol abuse or psychiatric condition, that in the opinion of the Investigator, will potentially interfere with participation
- •Has any medical condition that may increase the risk associated with intra-articular injections, to include (but are not limited to): thrombocytopenia, blood disorders treated with warfarin or anticoagulants, anemia or other concomitant diseases that, in the opinion of the Investigator, will interfere with the evaluation of the trial treatment, e.g., renal or liver disease, uncontrolled diabetes, significant cardiovascular, immune deficiency, or infectious disease
- •Is actively involved in a litigation involving Workers' Compensation
- •Is a female that is pregnant, planning to become pregnant or is lactating
- •Has participated in a clinical trial within the past four weeks
研究组 & 干预措施
EUFLEXXA
Experimental
ACTIVE CONTROL
干预措施: EUFLEXXA (Drug)
结局指标
主要结局
Number of Participants With a Reduction in Pain by the Scores.
时间窗: 6 months
Greater than 50 percent reduction in pain scores from baseline.
次要结局
未报告次要终点
研究者
Arnold J. Weil, M.D.
M.D./CEO/Principal Investigator
Georgia Institute for Clinical Research, LLC
研究点 (1)
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