NCT02003118已完成2 期
A Placebo Controlled, Double Blind, Randomised, 8-week Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of AKR 202 in Patients With Osteoarthritis Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- WOMAC
研究概览
简要总结
This proof of concept study will be a placebo controlled, randomised, double blind, parallel study. The purpose of the study is to determine efficacy for AKR 202 in the treatment of osteoarthritis (OA) pain in the knee.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patient is between 40 and 75 years of age with a clinical diagnosis of OA of the knee for more than 6 months prior to Visit 1 based on clinical and radiographic criteria, and being of American Rheumatism Association (ARA) functional Class I, II, or III. Patients should have an average pain level of between 4 and 8 on a Numeric Rating Scale (NRS) for at least 5 of 7 days before the randomisation, when answering the question: Please, rate the average pain in your index knee during the last 24 hours. Prior to the study, patients should have been using pharmacological treatments, such as Non-Steroidal Anti-Inflammatory Drug (NSAIDs), acetaminophen or weak opioids for their OA pain on a regular basis (defined as having used NSAIDs, acetaminophen or weak opioids at least 10 days out of 30 days during the last month prior to the screening visit).
排除标准
- •Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy.
- •Patients with impaired renal function, defined as an estimated creatinine clearance less than or equal to 50 ml/min, or patients taking medications that might impair renal function.
- •Patient has New York Heart Association (NYHA) Class III-IV congestive heart failure.
- •The patient has a history of uncontrolled hypertension or a current blood pressure that in the opinion of the Investigator makes the patient unsuitable for the study.
- •Patients with a trauma or surgery at the index knee within 3 months prior to screening.
研究组 & 干预措施
AKR 202
Experimental
干预措施: AKR 202 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
WOMAC
时间窗: 8 weeks
Change from baseline in WOMAC pain subscale at Week 8 or at the final visit at the time of patient discontinuation
次要结局
未报告次要终点
研究者
研究点 (1)
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