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 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
GERD Acid Reflux Disease Gastroesophageal Reflux Disease	Drug: Rabeprazole Sodium (Aciphex)	Phase IV

Further study details as provided by University of Arizona:

Primary Outcomes: Symptom control after 6 weeks of treatment.
Secondary Outcomes: number of drop-outs due to poor symptoms control; level of antacid consumption; improvement in quality of life
Expected Total Enrollment:  150

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male of 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, hematological, 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00251732

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

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

Study chairs or principal investigators

Ronnie Fass, MD,  Principal Investigator,  SAVAHCS   

Study ID Numbers:  Merit Review Study
Last Updated:  December 8, 2005
Record first received:  November 8, 2005
ClinicalTrials.gov Identifier:  NCT00251732
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10