A Long-Term, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Radiographic Study To Investigate The Safety And Efficacy Of Orally Administered SD-6010 In Subjects With Symptomatic Osteoarthritis Of The Knee
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,457
- 试验地点
- 172
- 主要终点
- Rate of Progression of Joint Space Narrowing
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), in overweight and obese subjects with knee osteoarthritis. 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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged >= 40 years with a BMI >= 25 and <= 40 kg/m2
- •In the past, has been diagnosed with knee 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
High dose active comparator
干预措施: SD-6010 (Drug)
50 mg
Low dose active comparator
干预措施: SD-6010 (Drug)
Placebo
Placebo comparator to be used for control purposes
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of Progression of Joint Space Narrowing
时间窗: Baseline up to Month 24
Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2
时间窗: Baseline up to Month 24
Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3
时间窗: Baseline up to Month 24
Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
次要结局
- Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24(Baseline, Month 3, 6, 12, 18, 24)
- Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24(Baseline, Month 12, 24)
- Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24(Baseline, Month 12, 24)
- Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24(Baseline, Month 12, 24)
- Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24(Baseline, Month 12, 24)
- Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24(Baseline, Month 12, 24)
- Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24(Baseline, Month 12, 24)
- Number of Participants With Joint Space Narrowing Progression(Month 24)
- Number of Participants Applicable for Virtual Joint Replacement(Month 24)
- Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24(Baseline, Month 12, 24)
- Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24(Baseline, Month 12, 24)
- Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24(Baseline, Month 12, 24)
- Number of Participants With EuroQoL-5D Self-Care Domain Score(Baseline, Month 12, 24)
- Number of Participants With EuroQoL-5D Usual Activity Domain Score(Baseline, Month 12, 24)
- Number of Participants With EuroQo-5D Pain and Discomfort Domain Score(Baseline, Month 12, 24)
- Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score(Baseline, Month 12, 24)
- EuroQoL-5D Visual Analog Scale Score(Baseline, Month 12, 24)
- Number of Participants With Increase in Total Analgesic Medication Use(Month 12, 24)
- Number of Participants With Decrease in Total Analgesic Medication Use(Month 12, 24)
- Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24(Baseline, Month 12, 24)
- Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score(Baseline, Month 12, 24)
- Patient Global Impression of Change Score(Month 24)
- Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index(Month 24)