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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251732
• Other study ID #: Merit Review Study
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2005
• Last updated: August 18, 2010
• Start date: March 2005
• Est. completion date: May 2010

Study information

• Verified date: August 2010
• Source: Southern Arizona VA Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Standard dose (once daily) PPI plus low-dose antidepressant
20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
• Double dose PPI plus evening placebo
20 mg. twice daily with a placebo
• Rabeprazole , placebo, placebo
20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime

Locations

Country	Name	City	State
United States	Southern Arizona VA Health Care System	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
University of Arizona	Janssen Pharmaceutica N.V., Belgium, Southern Arizona VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom control after 6 weeks of treatment	To measure the outcome after 6 weeks of treatment	6 weeks	No
Secondary	Number of drop-outs due to poor symptom control	To measure the number of drop-outs due to poor symptom control.	6 weeks	No
Secondary	Level of antacid consumption	To measure the level of antacid consumption due to poor symptom control.	6 weeks	No
Secondary	Improvement in quality of life	To improve quality of life with GERD symptom control.	6 weeks	No