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

NCT00251732 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-08-19

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

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

Sponsors & Collaborators

  • Southern Arizona VA Health Care System

    collaborator FED

  • Janssen Pharmaceutica N.V., Belgium

    collaborator INDUSTRY

  • University of Arizona

    lead OTHER

Principal Investigators

  • Ronnie Fass, MD · SAVAHCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251732 on ClinicalTrials.gov