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

This study is not yet open for participant recruitment.

Verified by University of Arizona, November 2005

First Received: November 8, 2005 Last Updated: July 18, 2006 History of Changes

Sponsor:	University of Arizona
Collaborators:	Southern Arizona VA Health Care System Janssen Pharmaceutica N.V., Belgium
Information provided by:	University of Arizona
ClinicalTrials.gov Identifier:	NCT00251732

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: Rabeprazole Sodium (Aciphex)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI.

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: E 3810

U.S. FDA Resources

Further study details as provided by University of Arizona:

Primary Outcome Measures:

symptom control after 6 weeks of treatment

Secondary Outcome Measures:

number of drop-outs due to poor symptom control
level of antacid consumption
improvement in quality of life

Estimated Enrollment:

150

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251732

Contacts

Contact: Diley Hernandez, BA

520-792-1450 ext 4510

diley.hernandez@med.va.gov

Locations

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

Sponsors and Collaborators

University of Arizona

Southern Arizona VA Health Care System

Janssen Pharmaceutica N.V., Belgium

Investigators

Principal Investigator:

Ronnie Fass, MD

SAVAHCS

More Information

No publications provided

Study ID Numbers:	Merit Review Study
Study First Received:	November 8, 2005
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00251732 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arizona:

acid reflux studies
efficacy of PPI therapy
failing PPI therapy
GERD
Acid Reflux Disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders

Deglutition Disorders
Digestive System Diseases
Proton Pump Inhibitors
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Rabeprazole

ClinicalTrials.gov processed this record on February 08, 2010