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

This study has been completed.
Sponsor:
Collaborators:
Southern Arizona VA Health Care System
Janssen Pharmaceutica N.V., Belgium
Information provided by:
Southern Arizona VA Health Care System
ClinicalTrials.gov Identifier:
NCT00251732
First received: November 8, 2005
Last updated: August 18, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
 Drug: Standard dose (once daily) PPI plus low-dose antidepressant
Drug: Double dose PPI plus evening placebo
Drug: Rabeprazole , placebo, placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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.

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants GERD
U.S. FDA Resources

Further study details as provided by Southern Arizona VA Health Care System:

Primary Outcome Measures:
  • Symptom control after 6 weeks of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To measure the outcome after 6 weeks of treatment


Secondary Outcome Measures:
  • Number of drop-outs due to poor symptom control [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To measure the number of drop-outs due to poor symptom control.

  • Level of antacid consumption [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To measure the level of antacid consumption due to poor symptom control.

  • Improvement in quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To improve quality of life with GERD symptom control.


Enrollment: 150
Study Start Date: March 2005
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard dose (PPI) plus low dose TCA
Standard dose Rabeprazole(PPI) plus low dose tricyclic antidepressant(TCA)
 Drug: Standard dose (once daily) PPI plus low-dose antidepressant
20 mg. rabeprazole plus low dose tricyclic antidepressant(TCA)
Other Names:
  • Aciphex-PPI
  • Nortriptyline-TCA
Active Comparator: Double dose PPI
Double dose proton pump inhibitor plus placebo
 Drug: Double dose PPI plus evening placebo
20 mg. twice daily with a placebo
Other Name: Aciphex-PPI, rabeprazole
Placebo Comparator: Standard dose PPI plus placebo x 2
Standard dose 20 mg. once daily plus Placebo before dinner and placebo before bedtime
 Drug: Rabeprazole , placebo, placebo
20 mg rabeprazole(PPI) once daily -a.m. placebo -p.m. placebo -bedtime
Other Names:
  • Aciphex-rabeprazole (PPI)
  • Nortriptyline-low-dose tricyclic antidepressant (TCA)

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251732

Locations
United States, Arizona
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
Sponsors and Collaborators
University of Arizona
Southern Arizona VA Health Care System
Janssen Pharmaceutica N.V., Belgium
Investigators
Principal Investigator: Ronnie Fass, MD SAVAHCS
  More Information

No publications provided

Responsible Party: Ronnie Fass MD, SArizonaVAHCS
ClinicalTrials.gov Identifier: NCT00251732     History of Changes
Other Study ID Numbers: Merit Review Study
Study First Received: November 8, 2005
Last Updated: August 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Southern Arizona VA Health Care System:
acid reflux studies
efficacy of PPI therapy
failing PPI therapy
GERD
Acid Reflux Disease

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 22, 2013