A Phase 2, Open-label Study to Evaluate Safety and Tolerability, and to Explore the Efficacy, of Dosing Regimens of Intraarticular 4975 in Patients With Chronic Moderate to Severe Pain of the Knee Associated With Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times
研究概览
简要总结
This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.
详细描述
This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated knee will be assessed before, during and after administration of the study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 aged 40 years or over.
- •Body mass index (BMI) of 35 or less.
- •History of OA of the knee for at least 1 year and has experienced pain in the target area for at least six months.
- •X-Ray of the target knee.
- •Willing and able to complete the study procedures.
排除标准
- •Female patients who are pregnant or lactating or who plan to get pregnant.
- •Clinically significant form of joint disease other than OA.
- •Medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study.
- •Prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty.
- •Arthroscopic surgery on the target knee within 6 months.
研究组 & 干预措施
100-200 µg CNTX-4975
single dose
干预措施: CNTX-4975 (Drug)
300-425 µg CNTX-4975
Total dose delivered as two separate lower doses
干预措施: CNTX-4975 (Drug)
600-700 µg CNTX-4975
Total dose delivered as two separate lower doses
干预措施: CNTX-4975 (Drug)
800 µg CNTX-4975
Total dose delivered as two separate lower doses
干预措施: CNTX-4975 (Drug)
900-1000 µg CNTX-4975
Total dose delivered as two separate lower doses
干预措施: CNTX-4975 (Drug)
结局指标
主要结局
To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times
时间窗: 12 Weeks
次要结局
- Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975(12 Weeks)
- Change from baseline to Week 12 in WOMAC subscale score(Baseline to 12 weeks)