Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 121
- 主要终点
- Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4
研究概览
简要总结
This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain.
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)
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 in the study knee
- •Able to walk without assistive walking devices, able to perform usual daily activities, and agree to maintain similar activity level throughout the study
排除标准
- •Chronic pain conditions other than knee osteoarthritis
- •Presence of bursitis, meniscus tear, ligament tear, or significant injury to the study knee within 1 year
- •Surgery to the study knee within 24 weeks
- •Treatment with hyaluronic acid in the study knee within 24 weeks
- •Treatment with corticosteroids in the study knee within 12 weeks
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- •Previous treatment with botulinum toxin of any serotype for any reason
研究组 & 干预措施
botulinum toxin Type A
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
干预措施: botulinum toxin Type A (Biological)
Placebo
A single 2 mL dose of Normal Saline (placebo) injected 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 Average Daily Worst Pain Intensity Score at Week 4
时间窗: Baseline, Week 4
The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.
Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8
时间窗: Baseline, Week 8
The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.
Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12
时间窗: Baseline, Week 12
The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.
次要结局
- Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score(Baseline, Week 8)
- Change From Baseline in WOMAC Pain Score(Baseline, Week 8)
- Change From Baseline in WOMAC Physical Function Score(Baseline, Week 8)
- Patient Global Impression of Change Score(Week 8)