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

Condition(s) targeted: Gastroesophageal Reflux Disease

Intervention: Rabeprazole Sodium (Aciphex) (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Arizona

Official(s) and/or principal investigator(s):
Ronnie Fass, MD, Principal Investigator, Affiliation: SAVAHCS

Overall contact:
Diley Hernandez, BA, Phone: 520-792-1450, Ext: 4510, Email: diley.hernandez@med.va.gov

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: symptom control after 6 weeks of treatment

Secondary outcome:

number of drop-outs due to poor symptom control

level of antacid consumption

improvement in quality of life

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Diley Hernandez, BA, Phone: 520-792-1450, Ext: 4510, Email: diley.hernandez@med.va.gov

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

Last updated: July 18, 2006