drugset / Trial / NCT00539240

Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI

NCT00539240

Phase 2/3 Completed 236 enrolled US Department of Veterans Affairs
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-04
Primary completion
2010-04
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nortriptyline Small molecule 50 mg
Comparator Rabeprazole Small molecule 20 mg