EUCTR2016-002675-97-DK进行中（未招募）1 期
A randomised, double-blind, placebo controlled, parallel group, multi-centre, study to evaluate the efficacy, safety, tolerability and pharmacokinetics of ONO-4474 in patients with pain due to osteoarthritis of the knee - MOTIO
Ono Pharmaceutical Co., Ltd.0 个研究点目标入组 280 人开始时间: 2016年10月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
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. Male or female (of non-childbearing potential) aged between 40 – 75 years inclusive at the time of signing the informed consent form
- •2. Symptomatic OA of the knee for =3 months diagnosed prior to screening as per American College of Rheumatology clinical criteria
- •3. Radiographic evidence of tibiofemoral OA of index knee (Kellgren-Lawrence grade 2-3), as confirmed at screening
- •4. Moderate to severe index knee pain due to OA requiring use of analgesic medication
- •5. Willing to discontinue use of all analgesic medication (aside from rescue medication) during the study
- •Other inclusion criteria will also be applied.
- •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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Presence of, or history of,
- •a. any inflammatory arthritis (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondylarthropathy, septic arthritis, previous diagnosis of pseudogout in target joint with proven crystals on joint aspiration or elevated C-Reactive Protein (CRP) at time of knee arthritis flare)
- •b. RPOA, osteonecrosis, osteoporotic fracture or any other painful joint disease other than OA
- •c. Secondary causes of OA; other rheumatologic or musculoskeletal conditions (e.g., rheumatoid arthritis, fibromyalgia, septic arthritis, congenital abnormality)
- •2. Orthopaedic surgery of a lower extremity or any major surgery within the previous 6 months prior to Visit 1 or has plans for surgical intervention during the study
- •3. Symptomatic hip OA
- •4. A history of partial or complete joint replacement surgery in the index knee at any time or anticipating knee surgery during the study period
- •5. Significant knee injury or any knee surgery (including arthroscopy) in the index knee within 6 months prior to screening
- •6. Patients with uncontrolled diabetes
- •Other exclusion criteria will also be applied.
研究者
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