NCT04044742撤回3 期
A Phase 3 Placebo-controlled Study to Evaluate the Efficacy and Safety of Intra-articular Administration of Resiniferatoxin Versus Placebo for the Treatment of Moderate to Severe Pain Due to 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
- 主要终点
- Change in index knee pain with walking
研究概览
简要总结
This study evaluates the efficacy and safety of intra-articular injection of resiniferatoxin in patients with moderate to severe knee pain due to osteoarthritis.
详细描述
This study is to evaluate the analgesic efficacy and safety of resiniferatoxin administered intra-articularly to subjects with moderate to severe knee pain due to osteoarthritis (OA).
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)
盲法说明
The treatment assigned to each subject is blinded to the subject, investigators, and sponsor study team.
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 35 to 85 years of age (inclusive).
- •Diagnosis of moderate to severe pain in the index knee due to OA.
- •Pain in the non-index knee is less than pain in the index knee.
- •Body mass index ≤40 kg/m².
- •Experienced treatment failure with at least 2 prior categories of therapies.
- •Able to understand and complete study-related forms and communicate with the Investigator and/or site staff.
排除标准
- •Evidence or history of a serious coagulopathy or hemostasis problem, such as inherited bleeding disorders or thrombocytopenia.
- •History of or current condition of poorly controlled hypertension, QTc prolongation, history of risk factors for Torsades de Pointes, or family history of long QT syndrome; or is using concomitant medications that prolong the QT interval.
- •Received index knee injections with corticosteroids within 30 days, or hyaluronic acid within 3 months, or platelet-rich plasma within 6 months prior to the injection day.
- •Pre-existing osteonecrosis, subchondral insufficiency fracture, severe bone on bone OA, or knee pain attributable to disease other than OA.
- •Instability or misalignment in the index knee.
- •Concurrent use of opioids or indications other than knee pain.
- •History within the past 2 years of substance abuse, including alcohol.
- •Allergy or hypersensitivity to chili peppers, capsaicin, resiniferatoxin, acetaminophen, tramadol, or radiographic contrast agents.
- •Female participants who are pregnant, planning on becoming pregnant, or currently breastfeeding.
- •Any medical condition or comorbidities that, in the Investigator's opinion, could adversely impact study participation or safety, conduct of the study, or interfere with pain assessments.
- •Sensory peripheral neuropathy that is of moderate severity or higher.
- •Arterial or venous thrombi (including stroke), myocardial infarction, hospital admission for unstable angina, cardiac angioplasty, or stenting within the past 12 months.
- •Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or hepatitis C. Participants with these viral infections who are receiving or have received antiviral treatment and have a viral load that is undetectable are eligible.
- •Concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee joint including chondromalacia patellae, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint.
- •Undergone arthroscopic surgery of the index knee within 6 months of the injection day, or open surgery to the index knee within 24 months of the injection day.
- •Undergone replacement surgery of the index knee.
- •Presence of surgical hardware or other foreign bodies in the index knee.
研究组 & 干预措施
Resiniferatoxin
Experimental
12.5 ug of Resiniferatoxin in 5 mL volume is administered as a one-time dose, intra-articularly
干预措施: Resiniferatoxin (Drug)
Placebo
Placebo Comparator
Placebo formulation in 5 mL volume administered intra-articularly
干预措施: Placebo (Drug)
结局指标
主要结局
Change in index knee pain with walking
时间窗: Baseline through Week 12
Change in the weekly mean of Average Daily Pain (ADP) scores in the index knee, using the 10-point Numerical Pain Rating Scale (NPRS)
次要结局
- Change in the average pain in the index knee(Baseline through Week 12, Week 26, and Week 52)
- Area under the curve (AUC) change in average pain in the index knee(Baseline through Week 12)
- Duration of effect of a single injection in the index knee(Baseline through return to Baseline)
- Change in the average stiffness in the index knee(Baseline through Week 12, Week 26, and Week 52)
- AUC change in average pain in the index knee(Baseline through Week 52)
- Change in index knee pain, stiffness, and physical function(Baseline through Week 12, Week 26, and Week 52)
- Change in quality of life (QOL) - SF-36 Health Survey(Baseline through Week 12, Week 26, and Week 52)
- Patient Global Impression of Change(At Week 12, Week 26, and Week 52)
- Change in QOL - EQ-5D-5L(Baseline through Week 12, Week 26, and Week 52)
- Change in index knee pain with walking(Baseline through Week 52)
- Change in the average function in the index knee(Baseline through Week 12, Week 26, and Week 52)
- Change in quality of sleep(Baseline through Week 12, Week 26, and Week 52)
研究者
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