Botulinum Toxin Injection in the Upper Esophageal Sphincter for Retrograde-cricopharyngeus Dysfunction: a Prospective, Double Blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- AZ Delta
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Response to Botox versus placebo, 12 weeks after treatment.
研究概览
简要总结
The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection).
This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Botulinum toxin injection
干预措施: botulinum toxin type A (Drug)
Placebo injection
干预措施: Sodium Chloride 0.9% Inj (Drug)
结局指标
主要结局
Response to Botox versus placebo, 12 weeks after treatment.
时间窗: week 12
This questionnaire is a treatment effect measure specific for inability to belch, where the change in symptoms from baseline is assessed, on a scale from 0% to 100%. 100% means complete resolution of symptoms, 0% means no improvement.
次要结局
- Response to botox versus placebo 48 weeks after treatment.(48 weeks)
- Safety: count of each type of (serious) adverse events in each group(4 weeks)
- Safety on swallowing: with SSQ(4 weeks)