Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Gastroesophageal Reflux Disease
In brief
The purpose of this project is to compare the efficacy (how successful) 1) standard-dose proton pump inhibitor (PPI) (rabeprazole 20 mg once daily) (a medication that completely blocks the stomach from producing acid) plus low dose tricyclic antidepressant (nortriptyline 50mg) (TCA); 2) double-dose PPI (rabeprazole 20 mg twice a day); to 3) standard-dose PPI (rabeprazole 20mg once daily) and placebo (an inactive substance, like a sugar pill) to determine the relative symptom resolution and health-related quality of life in gastroesophageal reflux disease (a disease characterized by a burning sensation (heartburn) behind the breast bone caused by a backflow of stomach contents into the esophagus) (GERD) patients who fail standard-dose PPI and you will be randomly assigned (similar to flipping a coin) to one of the three groups.
Key facts
- Study ID
- NCT00539240
- Run by
- US Department of Veterans Affairs
- People needed
- 236
- Starts
- 2006-04-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2014-08-18
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Currently being treated with a PPI, but continue to experience GERD symptoms (such as heartburn) at least 2 times per week.
You may not qualify if…
- Known allergy or intolerance to TCA
- 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
- With evidence or history of drug abuse within the past 6 months
- Erosive esophagitis, esophageal ulceration, peptic stricture, Barrett'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
- Insulin dependent diabetes
Where it is running
- Southern Arizona VA Health Care System, Tucson — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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