Bethanechol for Treatment of Eosinophilic Esophagitis (EoE)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7
研究概览
简要总结
The primary goals of this study are to ease the symptoms of patients with Eosinophilic Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or Female
- •Age 18-75
- •Symptoms associated with EoE such as dysphagia, heartburn, vomiting, abdominal pain, food impaction
- •Subject has signed informed consent for the administration of bethanechol that informs the patient of potential adverse events
- •Clinically or pathologically proven EoE
排除标准
- •Known allergy to bethanechol
- •Pregnant or breast-feeding women
- •Severe neurological problems
- •Severe diabetes
- •Achalasia
- •Known allergy to lidocaine or other local anesthetic
- •Hypothyroidism
- •Peptic ulcer
- •Pronounced bradycardia or hypotension
- •Vasomotor instability
- •Coronary artery disease
- •Parkinsonism
- •Weakened gastrointestinal or bladder wall
- •Mechanical obstruction of the gastrointestinal tract or bladder neck
- •Urinary bladder surgery in the 6 months prior to the study
- •Gastrointestinal resection and anastomosis
- •Spastic gastrointestinal disturbances
- •Acute inflammatory lesions of the gastrointestinal tract
- •Peritonitis
- •Marked vagotonia
研究组 & 干预措施
Bethanechol
Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.
干预措施: Bethanechol (Drug)
结局指标
主要结局
Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7
时间窗: Day 1 and Day 7
The high resolution esophageal manometry with impedance involves a thin, pressure-sensitive tube that is passed through the nose and into the stomach. Once in place, the tube is pulled slowly back into the esophagus (food pipe). When the tube is in the esophagus, the patient is asked to swallow several times while swallowing water, applesauce, crackers, and marshmallows. These swallows will be completed while laying down, sitting upright, and standing. The pressure of the muscle contractions will be measured along several sections of the tube. The tube is removed after the tests are completed. This test allows for a quantitative measure of the pressure in the esophagus that can be correlated to difficulty or ease of bolus swallowing.
次要结局
- Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7(Day 1 and Day 7)
研究者
Assouline-Dayan, Yehudith
Clinical Assistant Professor
University of Iowa