ACTRN12616001435471招募中不适用
A Phase 2 Study to Assess the Efficacy and Safety of CMX-020 in Treating Osteoarthritis.
Cytometix A0 个研究点目标入组 90 人开始时间: 2016年10月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •(1) Has satisfied the criteria of the American College of Rheumatology for a diagnosis of primary OA of the knee;
- •(2) Has a Functional Class of I, II, or III;
- •(3) Has satisfied the criteria of an OA flare;
- •(4) Has satisfied the criteria for a placebo non-responder”;
- •(5) If female is of non-childbearing potential, or is either practicing abstinence or using a medically acceptable form of contraception or double-barrier, is not lactating and has had a negative urine pregnancy test at Visit 1 and Visit 3;
- •(6) If male must agree to use a condom if engaging in sexual intercourse at any time during the duration of the study.
排除标准
- •(1) Has received oral, intramuscular, intra-articular or soft tissue injection of a corticosteroid within four weeks prior to enrollment into the study;
- •(2) NSAID or analgesic use within 5 days prior to Visit 3 (Baseline) assessment;
- •(3) Has a diagnosis of any inflammatory arthritis, gout, or acute trauma of the knee;
- •(4) Has an active GI tract, renal, hepatic, or a coagulation disorder;
- •(5) Has known hypersensitivity to analgesics, NSAIDs, celecoxib, COX-2 inhibitors, sulphonamides, acetaminophen (paracematol), or CMX-020.
研究者
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