NCT06169319已完成2 期
A Phase 2, Double-blind, Randomized, Placebo-controlled, Dose-ranging Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fasciitis (PFA)
Endo Pharmaceuticals39 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2024年1月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 39
- 主要终点
- Change from Baseline at Week 12 in the Weekly Mean of the Average Daily (24-hour) Pain (ADP) Score as Measured on the Pain Intensity Numeric Rating Scale (NRS)
研究概览
简要总结
This study will assess the efficacy, safety, and tolerability of 2 different doses of collagenase clostridium histolyticum (CCH) (previously known as EN3835) compared to placebo.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have no significant medical history or examination findings related to the foot to be treated, which in the investigator's opinion, would make the participant unsuitable for study intervention administration.
- •Have a diagnosis of plantar fasciitis for ≥6 months, which has not responded to conservative therapies. Conservative therapies may include rest, physical therapy, splinting/bracing, orthotics, icing, physiotherapy, acetaminophen, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs).
- •Have current foot pain due to plantar fasciitis.
排除标准
- •Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his/her feet and/or would impair his/her completion of study assessments as determined by the investigator either due to the disorder or due to pain.
- •Has a clinically meaningful laboratory abnormality.
- •Has a body mass index ≥35 kilograms per meter squared (kg/m^2).
- •Has a known bleeding disorder, which, in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
研究组 & 干预措施
Group 3: Placebo
Placebo Comparator
Participants will receive matching placebo on Day 1.
干预措施: Placebo (Biological)
Group 1: CCH High Dose
Experimental
Participants will receive a high dose of CCH on Day 1.
干预措施: Collagenase Clostridium Histolyticum (CCH) (Biological)
Group 2: CCH Low Dose
Experimental
Participants will receive a low dose of CCH on Day 1.
干预措施: Collagenase Clostridium Histolyticum (CCH) (Biological)
结局指标
主要结局
Change from Baseline at Week 12 in the Weekly Mean of the Average Daily (24-hour) Pain (ADP) Score as Measured on the Pain Intensity Numeric Rating Scale (NRS)
时间窗: Baseline, Week 12
次要结局
- Change from Baseline up to Day 85 in the FFI Pain Subscale Score(Baseline, up to Day 85)
- Patient Global Impression of Change (PGIC) Foot Pain Scale Score(Up to Day 85)
- Change from Baseline up to Day 85 in the FFI Activity Limitation Subscale Score(Baseline, up to Day 85)
- Change from Baseline up to Day 85 in the FFI Total Score(Baseline, up to Day 85)
- Change from Baseline up to Day 85 in the Foot Function Index (FFI) Difficulty Subscale Score(Baseline, up to Day 85)
- Number of Participants That Used Rescue Analgesic Medication(Up to Day 85)
- Total Amount (milligrams [mg]) of Rescue Analgesic Medication Used(Up to Day 85)
- Subject Satisfaction with Treatment Scale Score(Up to Day 85)
- Change from Baseline up to Week 12 in the Weekly Mean of the ADP Score as Measured on the Pain Intensity NRS(Baseline, up to Week 12)
- Clinician Global Impression of Change (CGIC) Scale Score(Up to Day 85)
研究者
研究点 (39)
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