A Randomized, Double-Blind, Placebo-Controlled, Phase I Trial Evaluating the Pharmacokinetics, Safety and Preliminary Efficacy of EP-104IAR (Long-Acting Fluticasone Propionate) in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Peak Plasma Concentration (Cmax) of fluticasone propionate
研究概览
简要总结
The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The study will also provide some preliminary insights into whether the experimental treatment reduces pain in the knee.
Osteoarthritis is the most common joint disease, affecting over 20 million people in the US alone. Currently, pain treatments that are injected directly into the knee often work for only a short time and may also have side effects within the rest of the body. The experimental treatment is a steroid that is in the same family of drugs as the most common current injectable treatments for knee osteoarthritis. For this study, the drug is coated with a polymer intended to prolong the time it stays inside the knee and lessen potential side effects.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OA of Index Knee
- •Kellgren Lawrence Grade 2 or 3
- •Patient-reported pain (PtPain) of Index Knee ≥4 but ≤9
- •PtPain of non-Index Knee <6
- •BMI ≦ 40 kg/m2
排除标准
- •Intra-articular joint injection in the Index Knee within the past 8 weeks for glucocorticoids and 6 months for hyaluronic acid
- •Insulin-dependent diabetes
- •Active infection
- •Pregnant or breast feeding
研究组 & 干预措施
EP-104IAR
15mg EP-104IAR in 4 mL carrier fluid
干预措施: EP-104IAR (Drug)
Vehicle
4 mL carrier fluid
干预措施: Vehicle (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of fluticasone propionate
时间窗: Up to 42 weeks
Fluticasone propionate concentrations in synovial fluid
时间窗: Up to 30 weeks
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
时间窗: 12 weeks
Incidence of treatment-emergent adverse events
时间窗: Up to 42 weeks
Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis
时间窗: Up to 42 weeks
次要结局
- Change from baseline in patient-reported Short Form - 36 quality of life scores(Up to 42 weeks)
- Change from baseline in Physician's Global Assessment of Arthritis(Up to 42 weeks)
- Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Up to 42 weeks)
- Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee(Weekly up to 42 weeks)
- Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee(Weekly up to 42 weeks)
- Change from baseline in patient-reported Global Assessment of Arthritis(Up to 42 weeks)