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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by (Responsible Party): | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00539240 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease |
Drug: Rabeprazole 20mg, placebo dinner and bedtime Drug: Rabeprazole 20 mg two times, Placebo at bedtime Drug: Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI |
| Enrollment: | 236 |
| Study Start Date: | April 2006 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
AciPhex 20 mg BID and once daily placebo
|
Drug: Rabeprazole 20mg, placebo dinner and bedtime
Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
Other Name: AcipHex
|
|
Placebo Comparator: 2
AcipHex 20 mg once daily and BID placebo
|
Drug: Rabeprazole 20 mg two times, Placebo at bedtime
Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
Other Name: Aciphex
|
|
Placebo Comparator: 3
AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
|
Drug: Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant
Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
Other Name: Nortriptyline and Aciphex
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Southern Arizona VA Health Care System, Tucson | |
| Tucson, Arizona, United States, 85723 | |
| Principal Investigator: | Ronnie Fass, MD | Southern Arizona VA Health Care System, Tucson |
More Information
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00539240 History of Changes |
| Other Study ID Numbers: | CLIN-022-04F |
| Study First Received: | October 3, 2007 |
| Last Updated: | November 17, 2011 |
| Health Authority: | United States: Federal Government |
|
acid reflux acid regurgitation esophagitis GERD |
heartburn pain peptic |
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Antidepressive Agents Nortriptyline Antidepressive Agents, Tricyclic Rabeprazole Proton Pump Inhibitors Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Anti-Ulcer Agents Gastrointestinal Agents |
