NCT01372475已完成3 期
A Multi-Centre, Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Safety And Effectiveness Of A New Viscoelastic Hydrogel (Hymovis) In The Treatment Of Knee OA With An Open-Label Extension
Fidia Farmaceutici s.p.a.33 个研究点 分布在 2 个国家目标入组 800 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 33
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score
研究概览
简要总结
Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline [PBS] in subjects with symptomatic osteoarthritis of the knee.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle:
- •Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3
- •Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study
排除标准
- •Clinically significant apparent large effusion of the target knee;
- •Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator;
- •Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease
- •Medical history of anaphylactic reactions
- •History of septic arthritis in any joint
- •Females who are pregnant or breast-feeding
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score
时间窗: 26 weeks
WOMAC A Pain sub-score
次要结局
- Responder Analysis(26 weeks)
- WOMAC Function(26 Weeks)
- Visual Analog Scale (VAS) WOMAC Pain(26 Weeks)
- WOMAC Global Score(26 Weeks)
- WOMAC Stiffness sub-score(26 Weeks)
- Rescue Medication Usage Pill Count, Failure Outcome(26 Weeks)
- Patient Global Analysis(26 Weeks)
- Clinician Responder Analysis(26 Weeks)
- SF Health Outcome(26 Weeks)
研究者
研究点 (33)
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