NCT03137407已完成2 期
A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 10
- 主要终点
- Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot
研究概览
简要总结
The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent, including authorization to release health information
- •Male or female subjects 18 to 65 years of age with diagnosis of plantar fasciitis
- •Persistent heel pain for more than three months
- •Women of child bearing potential must have negative pregnancy test at Screening and Injection Visits and must use an effective method of birth control during the course of the study
排除标准
- •Previous surgery on the midfoot or hindfoot
- •Neuromuscular disease
- •Systemic muscle weakness
- •Planning a pregnancy during the study
- •Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit
结局指标
主要结局
Change From Baseline at Week 8 in the Visual Analog Scale (VAS) for Pain for the Foot
时间窗: Week 8
The primary efficacy endpoint, as identified in the Statistical Analysis Plan (SAP) was the change from baseline in the visual analog scale (VAS) for pain for the affected foot at Week 8. The outcome was measured by means of a 100 mm VAS (0= no pain, 100= maximum pain) and higher reduction from baseline VAS pain scores means a better outcome.
次要结局
- Change From Baseline Through Week 16 for the American Orthopaedic Foot and Ankle Score (AOFAS)(Weeks 1, 2, 4, 8, and 16)
- Change From Baseline in Foot Pain as Measured by the Visual Analog Scale (VAS) Through Week 16(Weeks 1, 2, 4, 8, and 16)
- Change From Baseline Through Week 16 for the Foot and Ankle Disability Index(Weeks 1, 2, 4, 8, and 16)
研究者
研究点 (10)
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