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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539240
First Posted: October 4, 2007
Last Update Posted: August 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
October 3, 2007
October 4, 2007
February 7, 2014
August 18, 2014
August 18, 2014
April 2006
April 2010   (Final data collection date for primary outcome measure)
  • Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better) [ Time Frame: Symptom control after 6 weeks of treatment ]
    the number of days with Symptom Intensity Score < 3 (better) for daytime heartburn during week 6 as compared to baseline
  • Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline [ Time Frame: Symptom control after 6 weeks of treatment ]
    the number of days with Symptom Intensity Score < 3 (better) for nighttime heartburn during week 6 as compared to baseline
  • Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better) [ Time Frame: Symptom control after 6 weeks of treatment ]
    the number of days with Symptom Intensity Score < 3 (better) for acid regurgitation during week 6 as compared to baseline
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
Complete list of historical versions of study NCT00539240 on ClinicalTrials.gov Archive Site
Health Related Quality of Life [ Time Frame: end of study ]
SF-36 Physical Component Score (higher number better quality of life), is a measure of overall physical quality of life distinct from mental health. The range is 0 - 100. It has been adjusted to US national norms so that a score of 50 corresponds to the national mean.
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Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • 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
  • Drug: Rabeprazole 20 mg two times, Placebo at bedtime
    Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
    Other Name: Aciphex
  • 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
  • Placebo Comparator: Rabeprazole morning/evening placebo bedtime
    AciPhex 20 mg BID and once daily placebo
    Intervention: Drug: Rabeprazole 20 mg two times, Placebo at bedtime
  • Placebo Comparator: Rabeprazole breakfast, placebo dinner and bedtime
    AcipHex 20 mg once daily and BID placebo
    Intervention: Drug: Rabeprazole 20mg, placebo dinner and bedtime
  • Active Comparator: Rabeprazole breakfast, placebo dinner, nortriptyline bedtime
    AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
    Intervention: Drug: Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
236
November 2011
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00539240
CLIN-022-04F
Yes
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Not Provided
VA Office of Research and Development
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP