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| Name | Class |
|---|---|
| Southern Arizona VA Health Care System | FED |
| Janssen Pharmaceutica N.V., Belgium | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dose (PPI) plus low dose TCA | Active Comparator | Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA) |
|
| Double dose PPI | Active Comparator | Double dose proton pump inhibitor plus placebo |
|
| Standard dose PPI plus placebo x 2 | Placebo Comparator | Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard dose (once daily) PPI plus low-dose antidepressant | Drug | 20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom control after 6 weeks of treatment | To measure the outcome after 6 weeks of treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of drop-outs due to poor symptom control | To measure the number of drop-outs due to poor symptom control. | 6 weeks |
| Level of antacid consumption | To measure the level of antacid consumption due to poor symptom control. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronnie Fass, MD | SAVAHCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Arizona VA Health Care System | Tucson | Arizona | 85723 | United States |
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|
| Double dose PPI plus evening placebo | Drug | 20 mg. twice daily with a placebo |
|
|
| Rabeprazole , placebo, placebo | Drug | 20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime |
|
|
| 6 weeks |
| Improvement in quality of life | To improve quality of life with GERD symptom control. | 6 weeks |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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