NCT07226258招募中3 期
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 Injectable for the Treatment of Knee Pain in Patients With Osteoarthritis of the Knee
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 34
- 主要终点
- Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee.
详细描述
This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single treatment of SL1002 compared to placebo for the treatment of knee pain associated with mild to moderate osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 40 years of age
- •Body Mass Index (BMI) limits
- •Chronic knee pain resulting from osteoarthritis
- •Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)
- •Baseline KOOS pain
- •Patients taking baseline analgesics
- •Diagnostic nerve block response
- •Compliance with identified study requirements
排除标准
- •Non-OA inflammatory arthritis
- •Confounding elements
- •Lower limb amputation.
- •Specified alternate historic treatments
- •Identified underlying physiologic or psychosocial conditions
- •Patient Health Questionnaire
- •Moderate to severe hepatic impairment
- •Moderate to severe renal impairment
- •Identifiable baseline medications
- •Protocol compliance requirements
- •Known allergies or hypersensitivity to identified agents
- •Identified alcohol or drug abuse history
- •Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment
- •Identified underlying abnormal laboratory results
研究组 & 干预措施
Placebo
Placebo Comparator
Normal saline
干预措施: Normal Saline (Drug)
SL1002
Experimental
SL1002
干预措施: SL1002 (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking
时间窗: Baseline to week 12
The pain intensity score is measured using a numeric rating scale (NRS)
次要结局
未报告次要终点
研究者
研究点 (34)
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