Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Symptom control after 6 weeks of treatment
研究概览
简要总结
The main objective of this study is to evaluate the role of pain modulation in GERD patients who fail to obtain clinical relief with standard dose (once daily) PPI. The study will compare the efficacy of 1) standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.
详细描述
To evaluate the role of pain modulation in gastroesophageal reflux disease(GERD)patients who fail to obtain clinical relief with standard dose (once daily) proton pump inhibitor(PPI). The study will compare the efficacy; of 1)standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Ages 18 to 75
- •At least two episodes of heartburn per week while on PPI once daily
- •Able to communicate with the investigator and comply with the requirements of the study
- •Subjects who give written informed consent after being given a full description of the study.
排除标准
- •Known allergy or intolerance to TCA
- •Use of antidepressant or a diagnosis of depression
- •History of serious arrhythmia or use of anti-arrhythmics
- •History of seizures
- •Subjects with significant co-morbidity, e.g., cardiovascular, respiratory, urogenital, renal, gastrointestinal, hepatic, hematologic, endocrine, neurologic or psychiatric.
- •Evidence or history of drug abuse within the past 6 months
- •Erosive esophagitis, esophageal ulceration, peptic stricture, Barret's esophagus, or adenocarcinoma of the esophagus on endoscopy.
- •History of esophagogastric surgery
- •Gastric or duodenal lesions (ulcer, tumor, etc)
- •Women who are pregnant or of childbearing age who are not on contraception
- •Patients who are unwilling or unable to provide informed consent
研究组 & 干预措施
Standard dose (PPI) plus low dose TCA
Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)
干预措施: Standard dose (once daily) PPI plus low-dose antidepressant (Drug)
Double dose PPI
Double dose proton pump inhibitor plus placebo
干预措施: Double dose PPI plus evening placebo (Drug)
Standard dose PPI plus placebo x 2
Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime
干预措施: Rabeprazole , placebo, placebo (Drug)
结局指标
主要结局
Symptom control after 6 weeks of treatment
时间窗: 6 weeks
To measure the outcome after 6 weeks of treatment
次要结局
- Number of drop-outs due to poor symptom control(6 weeks)
- Level of antacid consumption(6 weeks)
- Improvement in quality of life(6 weeks)