A Multiple-dose, Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dysport for the Treatment of Pain Associated With Hallux Abducto Valgus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 186
- 试验地点
- 29
- 主要终点
- Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of treatment with multiple doses of Dysport in adults suffering from clinically significant pain associated with HAV who have not undergone surgery for their condition.
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
- •Clinical diagnosis of HAV
- •Painful HAV in the study foot at Baseline
排除标准
- •Flat or square metatarsal head, metatarsus primus elevates, or severe cavus/planus in the study foot
- •Other podiatric or orthopedic condition which would interfere with the evaluation of pain and/or function
- •Medical history or clinical evidence of any vascular disease and/or diabetic condition
研究组 & 干预措施
Placebo
Intramuscular injection of Placebo on day 1 of cycle 1 (double-blind period)
干预措施: Placebo (Drug)
Dysport Dose 1
Intramuscular injection of Dysport on day 1 of double-blind period, followed by up to 2 open-label injections during open-label cycles, during approximately 36 weeks.
干预措施: Botulinum toxin type A (Biological)
Dysport Dose 2
Intramuscular injection of Dysport on day 1 of double-blind period, followed by up to 2 open-label injections during open-label cycles, during approximately 36 weeks.
干预措施: Botulinum toxin type A (Biological)
结局指标
主要结局
Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8
时间窗: Baseline and Week 8 in the double-blind treatment period
The NPRS is a widely used and validated unidimensional measure of pain intensity in adults. Participants were asked to rate the intensity of their foot pain during physical activity (example, walking, standing or running) based on an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". Higher scores indicate a worse outcome. Daily pain intensities were recorded by the participant using an electronic diary (eDiary) for 7 consecutive days prior to each study visit. Baseline was defined as the daily NPRS score averaged over the 7 consecutive days prior to the Baseline visit (Day 1).
次要结局
- LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12 in the double-blind treatment period)
- LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12 in the double-blind treatment period)
- LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12 in the double-blind treatment period)
- Median Time to Retreatment(Up to 24 weeks in the double-blind treatment period)
- LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12 in the double-blind treatment period)
- LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12 in the double-blind treatment period)
- LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12(Baseline and Weeks 4 and 12 in the double-blind treatment period)
- LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12 in the double-blind treatment period)
- LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12 in the double-blind treatment period)
- LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12(Baseline and Weeks 4, 8 and 12 in the double-blind treatment period)
- LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12(Weeks 4, 8 and 12 in the double-blind treatment period)
- LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12(Weeks 4, 8 and 12 in the double-blind treatment period)
- Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12(Baseline and Weeks 8 and 12 in the double-blind treatment period)