drugset / Trial / NCT00251732
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
Phase 4
Completed
150 enrolled
University of Arizona
Janssen Pharmaceutica N.V., Belgium · collabSouthern Arizona VA Health Care System · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2005-03
- Primary completion
- 2010-05
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nortriptyline | Small molecule | — | — |
| Comparator | Rabeprazole | Small molecule | 20 mg | — |