The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Frequency of chest pain episodes in treatment vs placebo groups
研究概览
简要总结
The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would like to test its effectiveness in treating NCCP.
The patient will undergo esophageal balloon distention testing (EBDT) before and after taking the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical properties of the esophagus. A catheter with a deflated balloon is placed through the mouth and into the esophagus and the balloon is inflated with water. ECG and labs will be done throughout the study as a measurement of safety.
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
- Single (Participant)
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
- •Aged 18-75 years
- •NERD, or GERD LA Class A-B (endoscopy)
- •Subjects with positive pH testing
- •At least one episode of chest pain a week in the past month
- •Previous negative cardiac evaluation (EKG ± stress test ± coronary angiogram)
- •Negative esophageal evaluation for a motility disorder (Nutcracker esophagus, achalasia)
排除标准
- •Subjects requiring narcotics or other pain medications, Subjects with known LA class C-D, Barrett's esophagus or peptic stricture on endoscopy
- •Subjects with previous upper gastrointestinal surgery
- •Subjects with diabetes, neuromuscular disorders, or other severe co-morbidities
- •(Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric).
- •Subjects with upper airway symptoms (such as hoarseness, wheezing, laryngospasm).
- •Medications such as baclofen, and prokinetic agents.
- •History of substance abuse
研究组 & 干预措施
Dexilant
60mg of Dexilant QD for 12 weeks
干预措施: Dexilant (Drug)
Placebo
60mg of Dexilant placebo QD for 12 weeks
干预措施: Dexilant Placebo (Drug)
结局指标
主要结局
Frequency of chest pain episodes in treatment vs placebo groups
时间窗: 12 weeks
the number of chest pain episodes during the study
次要结局
- Intensity of chest pain episodes(12 weeks)
- Sensory thresholds for first sensation(12 weeks)
- Sensory thresholds for discomfort(12 weeks)
- Sensory thresholds for pain(12 weeks)
- duration of chest pain episodes(12 weeks)