EUCTR2017-003205-18-PL进行中（未招募）1 期
Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal®) to Provide Symptomatic Relief of Osteoarthritis of the Knee - not available
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 576
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
- 性别
- All
入选标准
- •1. Subjects meet the inclusion criteria for Cingal 16-02 and signed the informed consent.
- •2. Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.
- •Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.
- •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 519
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.
- •All patients enrolled in the Cingal 16-02 trial will be eligible to participate in Cingal 17-02.
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