Double-Blind, Parallel, Randomized, Placebo-Controlled 12-Week Efficacy and Safety Assessment of ZR-02-01 in the Treatment of Chronic, Moderate to Severe Osteoarthritis (OA) Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 13
- 主要终点
- WOMAC Knee and Hip Osteoarthritis Index
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.
详细描述
This study will evaluate the analgesic efficacy of the matrix fentanyl patch. The study will be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis (OA) pain. This patient population was chosen in anticipation that the patients are otherwise healthy adults being treated with NSAIDs (Nonsteroidal Anti-inflammatory Drugs) or acetaminophen or who have received intermittent opioid analgesic treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 40 and 75 years of age suffering from moderate to severe chronic pain caused by osteoarthritis.
排除标准
- •Patient is already taking chronic opioids or has a history of substance abuse or has a substance abuse disorder.
研究组 & 干预措施
ZR-02-01 matrix fentanyl Patch
ZR-02-01 matrix fentanyl patch
干预措施: ZR-02-01 Fentanyl Transdermal Matrix Patch (Drug)
Placebo Patch
干预措施: Placebo Patch (Drug)
结局指标
主要结局
WOMAC Knee and Hip Osteoarthritis Index
时间窗: 12 weeks
The Pain,Stiffness and Physical Function subscales of the WOMAC Knee and Hip Osteoarthritis Index (5-point Likert scale: none through extreme) was employed. The subscales consist of 24 questions (5 pain, 2 stiffness and 17 physical function)
次要结局
- Number of participants with adverse events(12 weeks)
- TOPS survey(12 weeks)