EUCTR2005-002735-27-LV进行中（未招募）1 期
A multicentre study to assess the safety and efficacy of sodium hyaluronate (Hyalgan-F) produced by fermentation in knee psteoarthritis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Male or female outpatients above 40 years of age, ambulant (only canes are allowed as assistive device),
- •-Suffering from primary knee osteoarthritis (OA) according to ACR diagnostic criteria (i.e., knee pain plus osteophytes + at least one of the following: age above 50 years, crepitus, morning stiffness above 30 minutes in duration) confirmed radiologically,
- •-OA of II-III degree according to Kellgren-Lawrence,
- •-Moderate-severe pain after the 50ft walk on a flat surface (above 40 mm VAS) at baseline,
- •-Discontinuation of analgesic/ NSAID therapy if previously taken prior to baseline,
- •-Willing and able to understand and sign an approved Infromed Consent Form,
- •-No pregnancy, not breast feeding. Females of childbearing potential (including those less than 1 year post-menopausal) must agree to maintain reliable birth control throughout the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- 未提供
研究者
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