A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of CNTX-4975 in Subjects With Painful Intermetatarsal Neuroma (Morton's Neuroma)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 15
- 主要终点
- Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS
研究概览
简要总结
Study 4975-MN-202 is a double-blind, placebo-controlled, parallel group, single-injection study in which subjects will be randomized to receive three doses of CNTX-4975 or placebo injected into the intermetatarsal space around a Morton's neuroma. The injection of study medication will be administered by ultrasound-guided needle placement following ankle block anesthesia. The study staff will telephone subjects at Week 1 postinjection and subjects will return to the clinic postinjection at Weeks 2, 4, 8, and 12 for study assessments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
2 mL injection of 200 µg of CNTX-4975
Single dose, 2 mL
干预措施: CNTX-4975 (Drug)
2 mL injection of 600 µg of CNTX-4975
Single dose, 2 mL
干预措施: CNTX-4975 (Drug)
2 mL injection of placebo
Single dose, 2 mL
干预措施: Placebo (Other)
2 mL injection of 25 µg of CNTX-4975
Single dose, 2 mL
干预措施: CNTX-4975 (Drug)
结局指标
主要结局
Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS
时间窗: Baseline (mean of Day -7 through Day -1), to week 4 (mean of Day 22 through Day 28)
Change from Baseline in average neuroma foot pain (Diary) with walking using the NPRS in subjects treated with CNTX-4975 compared with placebo.
次要结局
- Change from Baseline in average neuroma foot pain (Diary) with walking(Baseline (mean of Day -7 through Day -1), Week 1 through Week 12)
- Change from Baseline during the Follow-up Period in worst neuroma foot pain (Diary)(Baseline (mean of Day -7 through Day -1),, Week 1 through Week 12)
- Foot Function measured by FFI-R-R(Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12))
- Area under the curve (AUC) for average neuroma foot pain (Diary)(Baseline (mean of Day -7 through Day -1), to Week 12)
- QOL as measured by the EQ-5D.(Baseline (pre-dose Day 1) to each follow-up visit (Weeks 2, 4, 8, and 12))