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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
20 mg. twice daily with a placebo
20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Symptom control after 6 weeks of treatment
To measure the outcome after 6 weeks of treatment
Time frame: 6 weeks
Number of drop-outs due to poor symptom control
To measure the number of drop-outs due to poor symptom control.
Time frame: 6 weeks
Level of antacid consumption
To measure the level of antacid consumption due to poor symptom control.
Time frame: 6 weeks
Improvement in quality of life
To improve quality of life with GERD symptom control.
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.