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

Completed · Phase 4 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease

In brief

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.

Key facts

Study ID

NCT00251732

Run by

University of Arizona

People needed

150

Starts

2005-03-01

Expected to finish

2010-05-01

Last updated by the study team

2010-08-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Southern Arizona VA Health Care System — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.