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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Standard dose (once daily) PPI plus low-dose antidepressant
Double dose PPI plus evening placebo
Rabeprazole , placebo, placebo
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring acid reflux studies, efficacy of PPI therapy, failing PPI therapy, GERD, Acid Reflux Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern Arizona VA Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Standard dose (PPI) plus low dose TCA

Double dose PPI

Standard dose PPI plus placebo x 2

Arm Description

Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)

Double dose proton pump inhibitor plus placebo

Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime

Outcomes

Primary Outcome Measures

Symptom control after 6 weeks of treatment
To measure the outcome after 6 weeks of treatment

Secondary Outcome Measures

Number of drop-outs due to poor symptom control
To measure the number of drop-outs due to poor symptom control.
Level of antacid consumption
To measure the level of antacid consumption due to poor symptom control.
Improvement in quality of life
To improve quality of life with GERD symptom control.

Full Information

First Posted
November 8, 2005
Last Updated
August 18, 2010
Sponsor
University of Arizona
Collaborators
Southern Arizona VA Health Care System, Janssen Pharmaceutica N.V., Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT00251732
Brief Title
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
Official Title
Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arizona
Collaborators
Southern Arizona VA Health Care System, Janssen Pharmaceutica N.V., Belgium

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
acid reflux studies, efficacy of PPI therapy, failing PPI therapy, GERD, Acid Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard dose (PPI) plus low dose TCA
Arm Type
Active Comparator
Arm Description
Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)
Arm Title
Double dose PPI
Arm Type
Active Comparator
Arm Description
Double dose proton pump inhibitor plus placebo
Arm Title
Standard dose PPI plus placebo x 2
Arm Type
Placebo Comparator
Arm Description
Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime
Intervention Type
Drug
Intervention Name(s)
Standard dose (once daily) PPI plus low-dose antidepressant
Other Intervention Name(s)
Aciphex-PPI, Nortriptyline-TCA
Intervention Description
20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
Intervention Type
Drug
Intervention Name(s)
Double dose PPI plus evening placebo
Other Intervention Name(s)
Aciphex-PPI, rabeprazole
Intervention Description
20 mg. twice daily with a placebo
Intervention Type
Drug
Intervention Name(s)
Rabeprazole , placebo, placebo
Other Intervention Name(s)
Aciphex-rabeprazole (PPI), Nortriptyline-low-dose tricyclic antidepressant (TCA)
Intervention Description
20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
Primary Outcome Measure Information:
Title
Symptom control after 6 weeks of treatment
Description
To measure the outcome after 6 weeks of treatment
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of drop-outs due to poor symptom control
Description
To measure the number of drop-outs due to poor symptom control.
Time Frame
6 weeks
Title
Level of antacid consumption
Description
To measure the level of antacid consumption due to poor symptom control.
Time Frame
6 weeks
Title
Improvement in quality of life
Description
To improve quality of life with GERD symptom control.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronnie Fass, MD
Organizational Affiliation
SAVAHCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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