Placebo-controlled, Randomized, Double-blind, Cross-over Style Trial of Buspirone in Functional Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry
研究概览
简要总结
This study evaluates the utility of buspirone in patients who have a diagnosis of functional dysphagia. All participants will be randomized to receive either a placebo pill or buspirone. Subsequently, we will evaluate whether their swallowing is improved. Participants who were randomized to receive placebo will then receive buspirone and those who were receiving buspirone will receive placebo. We will again evaluate whether their swallowing improved.
详细描述
Buspirone helps to modulate molecules which can affect the activity of the muscles in the esophagus. Studies in the past have shown that in healthy people, buspirone can improve the vigor with which the esophagus squeezes to propel food into the stomach. In patients with functional dysphagia, the esophagus muscles may be weak (as defined by manometry).
Our two phase study will evaluate both symptoms of difficulty swallowing and the vigor with which the esophagus propels a bolus in patients after they 1) receive placebo pills and 2) receive buspirone pills.
We hypothesize that the placebo pills will not affect the vigor of the muscles or the symptoms of difficulty swallowing, but that buspirone will improve both outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IEM per Chicago Classification, v3.0 criteria - as noted above
- •Esophagogastroduodenoscopy (EGD) negative for mechanical obstruction
- •Esophageal biopsies negative for eosinophilic esophagitis
排除标准
- •Pregnant women
- •Prisoners
- •Currently on other serotonin modulating medications
研究组 & 干预措施
Buspirone then Placebo
Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks
干预措施: Buspirone (Drug)
Buspirone then Placebo
Buspirone 10 mg PO TID for two weeks, followed by a washout period for two weeks and placebo for two weeks
干预措施: Placebo (Drug)
Placebo then Buspirone
Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.
干预措施: Buspirone (Drug)
Placebo then Buspirone
Placebo Tablet TID for two weeks, followed by a washout period for two weeks and Buspirone 10mg TID for two weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry
时间窗: Change in the score from Baseline to 14 days
DCI is a measure of the strength of muscle contractions in the esophagus while swallowing. It is measured in mm Hg, and values greater than 450mm Hg are considered Normal.
次要结局
- Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.(14 days)
- Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score(Change in the score from Baseline to 14 days)
研究者
Scott Gabbard, MD
MD
The Cleveland Clinic