Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Arizona
Collaborators:
Janssen Pharmaceutica N.V., Belgium Southern Arizona VA Health Care System