Gastroesophageal Reflux Disease
Conditions
Keywords
acid reflux studies, efficacy of PPI therapy, failing PPI therapy, GERD, Acid Reflux Disease
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 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.
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 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.
Interventions
DRUGStandard dose (once daily) PPI plus low-dose antidepressant
20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
DRUGDouble dose PPI plus evening placebo
20 mg. twice daily with a placebo
DRUGRabeprazole , placebo, placebo
20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
Sponsors
Southern Arizona VA Health Care System
Janssen Pharmaceutica N.V., Belgium
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom control after 6 weeks of treatment | 6 weeks | To measure the outcome after 6 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of drop-outs due to poor symptom control | 6 weeks | To measure the number of drop-outs due to poor symptom control. |
| Level of antacid consumption | 6 weeks | To measure the level of antacid consumption due to poor symptom control. |
| Improvement in quality of life | 6 weeks | To improve quality of life with GERD symptom control. |
Countries
United States
Outcome results
None listed