Compare How Effective Standard Dose Proton Pump Inhibitor (PPI) and Low Dose Tricyclic Antidepressant and Double Dose PPI to Standard Dose PPI and Placebo
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease
Intervention: Rabeprazole 20mg, placebo dinner and bedtime (Drug); Rabeprazole 20 mg two times, Placebo at bedtime (Drug); Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Ronnie Fass, MD, Principal Investigator, Affiliation: Southern Arizona VA Health Care System, Tucson
Overall contact:
Marcia Willis, BA CCRC, Email: marcia.willis@va.gov
Summary
The purpose of this project is to compare the efficacy (how successful) 1) standard-dose
proton pump inhibitor (PPI) (rabeprazole 20 mg once daily) (a medication that completely
blocks the stomach from producing acid) plus low dose tricyclic antidepressant
(nortriptyline 50mg) (TCA); 2) double-dose PPI (rabeprazole 20 mg twice a day); to 3)
standard-dose PPI (rabeprazole 20mg once daily) and placebo (an inactive substance, like a
sugar pill) to determine the relative symptom resolution and health-related quality of life
in gastroesophageal reflux disease (a disease characterized by a burning sensation
(heartburn) behind the breast bone caused by a backflow of stomach contents into the
esophagus) (GERD) patients who fail standard-dose PPI and you will be randomly assigned
(similar to flipping a coin) to one of the three groups.
Clinical Details
Official title: Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the role of pain modulation in GERD patients who fail to obtain clinical relief with standard dose (once daily) PPI. We will compare the efficacy of 1) standard dose PPI plus low-dose TCA to 2) double dose PPI to 3) standard dose PPI and placebo
Detailed description:
Failure of standard dose PPI to control GERD symptoms has been increasingly encountered in
clinical practice (both primary care and sub-specialties) and has become one of the most
challenging therapeutic dilemmas in GERD management. It has been estimated that up to 30%
of the patients receiving PPI once daily will continue to report typical GERD symptoms [1].
Presently, increasing the PPI dose has been the standard of care in these patients [2].
However, success in relieving refractory GERD symptoms with such a therapeutic approach has
been extremely limited, resulting in frustration of both the patient as well as the health
care provided. Furthermore, patients who fail PPI will continue to seek medical attention
and may undergo a variety of invasive or non-invasive tests, and thus consume already
limited health care resources. Recent advancement in the understanding of the diverse
composition of the different GERD groups as well as symptom generation has led to the
recognition of alteration in pain perception as an important contributing factor for PPI
failure in some and the presence of non-acid related stimuli in others [3].
This study will clarify for the first time the role of pain modulation in patients who
failed standard dose of PPI. The clinical experience with doubling the PPI dose, which is
the current standard of care, has been very limited and relatively disappointing.
Additionally, this study may identify the group of PPI failure patients that may benefit
from doubling the dose of PPI and the group that will benefit more from adding a pain
modulator. This study is timely, has never been performed and addresses a prevalent
emerging clinical dilemma in GI as well as primary care clinics.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Currently being treated with a PPI, but continue to experience GERD symptoms (such as
heartburn) at least 2 times per week.
Exclusion Criteria:
- Known allergy or intolerance to TCA
- 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, hematological, endocrine, neurologic or
psychiatric
- With evidence or history of drug abuse within the past 6 months
- Erosive esophagitis, esophageal ulceration, peptic stricture, Barrett'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
- Insulin dependent diabetes
Locations and Contacts
Marcia Willis, BA CCRC, Email: marcia.willis@va.gov
Southern Arizona VA Health Care System, Tucson, Tucson, Arizona 85723, United States; Recruiting
Marcia Willis, BA CCRC, Email: marcia.willis@va.gov
Sheila Ojendyk, Phone: (520) 792-1450, Ext: 5537, Email: sheila.ojendyk@va.gov
Ronnie Fass, MD, Principal Investigator
Additional Information
Starting date: April 2006
Ending date: February 2010
Last updated: August 11, 2009
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