Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Arizona
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Symptom control after 6 weeks of treatment
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Standard dose (PPI) plus low dose TCA
Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)
Intervention: Standard dose (once daily) PPI plus low-dose antidepressant (Drug)
Double dose PPI
Double dose proton pump inhibitor plus placebo
Intervention: 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
Intervention: Rabeprazole , placebo, placebo (Drug)
Outcomes
Primary Outcomes
Symptom control after 6 weeks of treatment
Time Frame: 6 weeks
To measure the outcome after 6 weeks of treatment
Secondary Outcomes
- Number of drop-outs due to poor symptom control(6 weeks)
- Level of antacid consumption(6 weeks)
- Improvement in quality of life(6 weeks)