NCT02997696终止2 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 19
- 主要终点
- Change from baseline in mean daily average index knee pain while walking
研究概览
简要总结
The purpose of this phase 2, randomised, double-blind, placebo controlled, parallel group, multicentre study is to investigate the efficacy, safety, tolerability and pharmacokinetics of a compound ONO-4474 in patients with moderate to severe pain due to osteoarthritis of the knee following 4 weeks of oral administration of ONO-4474.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic OA of the knee for ≥3 months diagnosed prior to screening as per American College of Rheumatology clinical criteria.
- •Radiographic evidence of tibiofemoral OA of index knee (Kellgren-Lawrence grade 2-3), as confirmed at screening.
- •Moderate to severe index knee pain due to OA requiring use of analgesic medication.
- •Willing to discontinue use of all analgesic medication (aside from rescue medication) during the study.
排除标准
- •Presence of, or history of,
- •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),
- •RPOA, osteonecrosis, osteoporotic fracture or any other painful joint disease other than OA,
- •Secondary causes of OA; other rheumatologic or musculoskeletal conditions (e.g., rheumatoid arthritis, fibromyalgia, septic arthritis, congenital abnormality).
- •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.
- •Symptomatic hip OA.
- •A history of partial or complete joint replacement surgery in the index knee at any time or anticipating knee surgery during the study period.
- •Significant knee injury or any knee surgery (including arthroscopy) in the index knee within 6 months prior to screening.
- •Uncontrolled diabetes.
研究组 & 干预措施
Experimental arm 1
Experimental
ONO-4474 low dose every day for 4 weeks
干预措施: ONO-4474 (Drug)
Experimental arm 2
Experimental
ONO-4474 high dose every day for 4 weeks
干预措施: ONO-4474 (Drug)
Placebo arm
Placebo Comparator
Placebo matching ONO-4474 every day for 4 weeks
干预措施: Placebo matching ONO-4474 (Drug)
结局指标
主要结局
Change from baseline in mean daily average index knee pain while walking
时间窗: Week 4
次要结局
- Safety of ONO-4474 as assessed by neurological examination(From baseline to study completion, an average of 6 weeks)
- Change from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain, stiffness and physical function scores(Week 1, Week 2, Week 4 and Weeks 1-4)
- Change from baseline in Patient Global Assessment(Week 1, Week 2, Week 4 and Weeks 1-4)
- Pharmacokinetics of ONO-4474 in plasma: Ctrough of ONO-4474(Week 1, Week 2 and Week 4)
- Change from baseline in mean daily average index knee pain while walking(Week 1, Week 2, Week 3 and Weeks 1-4)
- Improvement score in Clinical Global Impression(Week 1, Week 2, Week 4 and Weeks 1-4)
- Change from baseline in overall WOMAC score(Week 1, Week 2, Week 4 and Weeks 1-4)
- Change from baseline in mean daily average index knee pain(Week 1, Week 2, Week 3, Week 4 and Weeks 1-4)
- Use of rescue medication as total number of tablets taken(Week 1, Week 2, Week 3, Week 4)
- Safety profile assessed by adverse events, vital signs, laboratory tests, 12-lead electrocardiograms (ECG), physical examination(From baseline to study completion, an average of 6 weeks)
- Safety of ONO-4474 as assessed by C-SSRS (evaluation of suicidal ideation and behavior)(From baseline to study completion, an average of 6 weeks)
- Change from baseline in: EuroQoL EQ-5D-5L(Week 4)
- Time to first rescue medication use(Week 4)
研究者
研究点 (19)
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