NCT01463488已完成1 期
A Two Part Protocol to Assess, Using Double Blind Placebo Control, the Safety, Tolerability, and Pharmacokinetics of Ascending Single Doses of a New Intra-articular Administration Formulation of SAR113945 (IKK Inhibitor) Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose in Patients With Knee Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain, Stiffness and Physical Function sub-scales from the WOMAC Index
研究概览
简要总结
Study objectives:
- Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.
- Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.
详细描述
- Screening will be performed within 28 days of dosing. Following the single dose of study medication, the study period for each patient will be 168 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR113945 - Dose 1
Experimental
干预措施: SAR113945 (Drug)
SAR113945 - Dose 2
Experimental
干预措施: SAR113945 (Drug)
SAR113945 - Dose 3
Experimental
干预措施: SAR113945 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Pain, Stiffness and Physical Function sub-scales from the WOMAC Index
时间窗: during 24 weeks
Number of patients reporting Adverse Events of special interest: tolerability at the site of injection and in the knee + other events reported by the patient
时间窗: during 24 weeks
次要结局
- Pharmacokinetics (Cmax)(during 24 weeks)
- Pharmacokinetics (AUC)(during 24 weeks)
- Pharmacokinetics (t1/2)(during 24 weeks)
- synovial fluid levels(during 24 weeks)
研究者
研究点 (1)
Loading locations...
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