Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this project is to compare the efficacy (how successful) 1) standard-dose
proton pump inhibitor (PPI) (rabeprazole 20 mg once daily) (a medication that completely
blocks the stomach from producing acid) plus low dose tricyclic antidepressant (nortriptyline
50mg) (TCA); 2) double-dose PPI (rabeprazole 20 mg twice a day); to 3) standard-dose PPI
(rabeprazole 20mg once daily) and placebo (an inactive substance, like a sugar pill) to
determine the relative symptom resolution and health-related quality of life in
gastroesophageal reflux disease (a disease characterized by a burning sensation (heartburn)
behind the breast bone caused by a backflow of stomach contents into the esophagus) (GERD)
patients who fail standard-dose PPI and you will be randomly assigned (similar to flipping a
coin) to one of the three groups.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
US Department of Veterans Affairs VA Office of Research and Development