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Sponsors and Collaborators: |
University of Arizona Southern Arizona VA Health Care System Janssen Pharmaceutica N.V., Belgium |
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Information provided by: | University of Arizona |
ClinicalTrials.gov Identifier: | NCT00251732 |
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 |
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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. |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Diley Hernandez, BA | 520-792-1450 ext 4510 | diley.hernandez@med.va.gov |
United States, Arizona | |
Southern Arizona VA Health Care System | |
Tucson, Arizona, United States, 85723 |
Principal Investigator: | Ronnie Fass, MD | SAVAHCS |
Study ID Numbers: | Merit Review Study |
Study First Received: | November 8, 2005 |
Last Updated: | July 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00251732 |
Health Authority: | United States: Food and Drug Administration |
acid reflux studies efficacy of PPI therapy failing PPI therapy GERD Acid Reflux Disease |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal disorder Gastrointestinal Diseases |
Pain Esophageal Diseases Gastroesophageal Reflux Rabeprazole |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |