Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
NCT ID: NCT00251732
Last Updated: 2010-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
150 participants
INTERVENTIONAL
2005-03-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Standard dose (PPI) plus low dose TCA
Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)
Standard dose (once daily) PPI plus low-dose antidepressant
20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
Double dose PPI
Double dose proton pump inhibitor plus placebo
Double dose PPI plus evening placebo
20 mg. twice daily with a placebo
Standard dose PPI plus placebo x 2
Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime
Rabeprazole , placebo, placebo
20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
Interventions
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Standard dose (once daily) PPI plus low-dose antidepressant
20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
Double dose PPI plus evening placebo
20 mg. twice daily with a placebo
Rabeprazole , placebo, placebo
20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Southern Arizona VA Health Care System
FED
Janssen Pharmaceutica N.V., Belgium
INDUSTRY
University of Arizona
OTHER
Responsible Party
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SArizonaVAHCS
Principal Investigators
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Ronnie Fass, MD
Role: PRINCIPAL_INVESTIGATOR
SAVAHCS
Locations
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Southern Arizona VA Health Care System
Tucson, Arizona, United States
Countries
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Other Identifiers
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Merit Review Study
Identifier Type: -
Identifier Source: org_study_id
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