Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)

University of Arizona

Status and phase: Completed; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Double dose PPI plus evening placebo; Drug: Rabeprazole , placebo, placebo; Drug: Standard dose (once daily) PPI plus low-dose antidepressant

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT00251732

Merit Review Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

Standard dose (PPI) plus low dose TCA

Active Comparator group

Description:

Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)

Treatment:

Drug: Standard dose (once daily) PPI plus low-dose antidepressant

Double dose PPI

Active Comparator group

Description:

Double dose proton pump inhibitor plus placebo

Treatment:

Drug: Double dose PPI plus evening placebo

Standard dose PPI plus placebo x 2

Placebo Comparator group

Description:

Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime

Treatment:

Drug: Rabeprazole , placebo, placebo