Status:
COMPLETED
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Southern Arizona VA Health Care System
Janssen Pharmaceutica N.V., Belgium
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
To evaluate the role of pain modulation in gastroesophageal reflux disease(GERD)patients who fail to obtain clinical relief with standard dose (once daily) proton pump inhibitor(PPI). The study will c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00251732
Start Date
March 1 2005
End Date
May 1 2010
Last Update
August 19 2010
Active Locations (1)
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1
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723