Clinical trial NCT00251732: Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)
Official title: Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Keywords: acid reflux studies
efficacy of PPI therapy
failing PPI therapy
GERD
Acid Reflux Disease
Lead sponsor: Southern Arizona VA Health Care System
Sponsor class: FED
Collaborators: name: Southern Arizona VA Health Care System
name: Janssen Pharmaceutica N.V., Belgium
First posted: 2005-11-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom control after 6 weeks of treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of drop-outs due to poor symptom control
timeFrame: 6 weeks
measure: Level of antacid consumption
timeFrame: 6 weeks
measure: Improvement in quality of life
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
Study officials:
affiliation: SAVAHCS
name: Ronnie Fass, MD
role: PRINCIPAL_INVESTIGATOR
References: