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

Phase 4

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Standard dose (once daily) PPI plus low-dose antidepressant; Drug: Double dose PPI plus evening placebo; Drug: Rabeprazole , placebo, placebo

• Registration Number: NCT00251732
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-11-08
• Study First Submitted QC: 2005-11-08
• Study First Posted: 2005-11-10
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-18
• Last Update Posted: 2010-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose (PPI) plus low dose TCA	Standard dose (once daily) PPI plus low-dose antidepressant	Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)
Double dose PPI	Double dose PPI plus evening placebo	Double dose proton pump inhibitor plus placebo
Standard dose PPI plus placebo x 2	Rabeprazole , placebo, placebo	Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime

Primary Outcome Measures

Name	Time	Method
Symptom control after 6 weeks of treatment	6 weeks	To measure the outcome after 6 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States