NCT00251732

Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Standard dose (once daily) PPI plus low-dose antidepressant	20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
DRUG	Double dose PPI plus evening placebo	20 mg. twice daily with a placebo
DRUG	Rabeprazole , placebo, placebo	20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime

Timeline

• Start date: 2005-03-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2005-11-10
• Last updated: 2010-08-19

Locations

1 site across 1 country: United States