A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 39
- 主要终点
- Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection versus placebo for the management of Plantar Fasciitis.
详细描述
Approximately 150 subjects, recruited from approximately 20 study centers in the United States (US) will be randomized to DAXI (HIGH-dose; LOW-dose) or placebo group, respectively.
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)
盲法说明
Double Blinded
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 unilateral plantar fasciitis.
- •Persistent heel pain.
- •Women of child bearing potential must have a negative pregnancy test at Screening and Injection Visits and must use an effective method of contraception during the course of the study.
排除标准
- •Previous injection of botulinum toxin in the lower extremities or feet.
- •Previously suffered a partial or full thickness tear or surgery of the plantar fascia within the 5 years preceding participation in the investigation.
- •Pregnant, nursing, or 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.
- •Any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the trial results, or may interfere significantly with the subject's participation in the trial.
结局指标
主要结局
Change From Baseline at Week 8 in the Numeric Pain Rating Scale (NPRS) Score
时间窗: Week 8
Change from baseline in the Numeric Pain Rating Scale (NPRS) score, which is recorded within 15 minutes after stepping out of bed in the morning and averaged over 5 days (defined as 4 days prior to study visit and on the study visit day), at Week 8. The outcome was measured by an 11-point scale scored from 0-10 where 0 is no pain and 10 is the worst pain imaginable.
次要结局
- Proportion of Subjects With a Decrease From Baseline of >= 20% in NPRS(Week 8)
- Change From Baseline at Week 8 in Foot Function Index (FFI)(Week 8)