NCT01438918撤回3 期
A Long-term, Confirmatory, Phase 3, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Investigate The Safety And Efficacy Of Orally Administered Sd-6010 In Subjects With Symptomatic Osteoarthritis Of The Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- To assess the progression rate of joint space narrowing in the study knee of subjects with knee OA over a 24-month period
研究概览
简要总结
The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS). The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged >= 40 years Diagnosed with knee OA (ACR definition of OA) Radiographic evidence of OA in the study knee
排除标准
- •A diagnosis of any other rheumatic disease Current conditions in the study knee that would confound efficacy Selected, traditional clinical safety and laboratory parameters
研究组 & 干预措施
200 mg
Active Comparator
High dose active comparator
干预措施: SD-6010 (Drug)
50 mg
Active Comparator
Low dose active comparator
干预措施: SD-6010 (Drug)
Placebo
Placebo Comparator
Placebo comparator to be used for control purposes
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the progression rate of joint space narrowing in the study knee of subjects with knee OA over a 24-month period
时间窗: 24 months
次要结局
- Clinical benefit of SD 6010 will be measured from changes in response from baseline to 24 months in 7 patient reported outcomes (PRO), including, but not limited to, WOMAC, pain VAS, ICOAP, KOOS.(24 months)
- Total analgesic medication burden for OA in the study knee will be compared back to baseline of an increased, sustained use of standard background and/or rescue medication for more than 30 days as measured at the Month 12 and 24 visits(24 months)
- Safety: Change from baseline to M24 in vital signs (blood pressure, heart rate) measurements will be assessed(24 months)
- Safety: Change from baseline to M24 in ECG abnormalities(24 months)
- Safety: In a subset of subjects: Change from baseline on average as assessed by 24-h ambulatory blood pressure monitoring (ABPM) at months 3 and 6(6 months)
研究者
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