BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 176
- 主要终点
- Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale
研究概览
简要总结
This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.
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
- Triple (Participant, 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
- •Painful osteoarthritis
- •Able to discontinue anti-inflammatory drugs and analgesics
- •Must be ambulatory without assistive walking devices
排除标准
- •Chronic pain conditions other than knee osteoarthritis
- •Treatment with corticosteroids in the study knee within 12 weeks
- •Treatment with hyaluronic acid in the study knee within 24 weeks
- •Previous treatment with any botulinum toxin for any reason
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
研究组 & 干预措施
OnabotulinumtoxinA 400 U
OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
干预措施: onabotulinumtoxinA (Biological)
OnabotulinumtoxinA 200 U
OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
干预措施: onabotulinumtoxinA (Biological)
Placebo
Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale
时间窗: Baseline, Week 8
Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
次要结局
- Patient Global Impression of Change (GIC) Using a 7-Point Scale(Weeks 1, 4, 8, 12, 16, 20 and 24)
- Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale(Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24)
- Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale(Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24)
- Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale(Baseline, Week 24)