NCT02973269终止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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)
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
- •Skeletally mature, male or female patients 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 a negative urine pregnancy test (UPT) at Screening Visit 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
研究组 & 干预措施
DAXI 240 U
Experimental
DaxibotulinumtoxinA for injection for the treatment of plantar fasciitis (PF) with 240 U
干预措施: daxibotulinumtoxin type A (Biological)
Placebo
Placebo Comparator
Placebo Intramuscular injection
干预措施: Placebo (Biological)
结局指标
主要结局
Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS)
时间窗: 16 weeks
The American Orthopaedic Foot and Ankle Score (AOFAS) is a 9-item questionnaire that evaluates pain, function, and alignment of the foot and ankle. The total score ranges from 0 to 100, with lower scores representing greater pain and disability, and higher scores representing better function.
次要结局
未报告次要终点
研究者
研究点 (1)
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