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

August 18, 2010 updated by: University of Arizona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female
  • Ages 18 to 75
  • At least two episodes of heartburn per week while on PPI once daily
  • Able to communicate with the investigator and comply with the requirements of the study
  • Subjects who give written informed consent after being given a full description of the study.

Exclusion Criteria:

  • Known allergy or intolerance to TCA
  • Use of antidepressant or a diagnosis of depression
  • History of serious arrhythmia or use of anti-arrhythmics
  • History of seizures
  • Subjects with significant co-morbidity, e.g., cardiovascular, respiratory, urogenital, renal, gastrointestinal, hepatic, hematologic, endocrine, neurologic or psychiatric.
  • Evidence or history of drug abuse within the past 6 months
  • Erosive esophagitis, esophageal ulceration, peptic stricture, Barret's esophagus, or adenocarcinoma of the esophagus on endoscopy.
  • History of esophagogastric surgery
  • Gastric or duodenal lesions (ulcer, tumor, etc)
  • Women who are pregnant or of childbearing age who are not on contraception
  • Patients who are unwilling or unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard dose (PPI) plus low dose TCA
Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)
Drug: Standard dose (once daily) PPI plus low-dose antidepressant
20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
Other Names:
  • Aciphex-PPI
  • Nortriptyline-TCA
Active Comparator: Double dose PPI
Double dose proton pump inhibitor plus placebo
Drug: Double dose PPI plus evening placebo
20 mg. twice daily with a placebo
Other Names:
  • Aciphex-PPI, rabeprazole
Placebo Comparator: Standard dose PPI plus placebo x 2
Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime
Drug: Rabeprazole , placebo, placebo
20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
Other Names:
  • Aciphex-rabeprazole (PPI)
  • Nortriptyline-low-dose tricyclic antidepressant (TCA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom control after 6 weeks of treatment
Time Frame: 6 weeks
To measure the outcome after 6 weeks of treatment
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of drop-outs due to poor symptom control
Time Frame: 6 weeks
To measure the number of drop-outs due to poor symptom control.
6 weeks
Level of antacid consumption
Time Frame: 6 weeks
To measure the level of antacid consumption due to poor symptom control.
6 weeks
Improvement in quality of life
Time Frame: 6 weeks
To improve quality of life with GERD symptom control.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

Janssen Pharmaceutica N.V., Belgium
Southern Arizona VA Health Care System

Investigators

  • Principal Investigator: Ronnie Fass, MD, SAVAHCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 8, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 10, 2005

Study Record Updates

Last Update Posted (Estimate)

August 19, 2010

Last Update Submitted That Met QC Criteria

August 18, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Merit Review Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroesophageal Reflux Disease

Clinical Trials on Standard dose (once daily) PPI plus low-dose antidepressant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe