Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
1 other identifier
interventional
236
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 3, 2007
CompletedFirst Posted
Study publicly available on registry
October 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
August 18, 2014
CompletedAugust 18, 2014
July 1, 2014
4 years
October 3, 2007
February 7, 2014
July 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better)
the number of days with Symptom Intensity Score \< 3 (better) for daytime heartburn during week 6 as compared to baseline
Symptom control after 6 weeks of treatment
Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline
the number of days with Symptom Intensity Score \< 3 (better) for nighttime heartburn during week 6 as compared to baseline
Symptom control after 6 weeks of treatment
Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better)
the number of days with Symptom Intensity Score \< 3 (better) for acid regurgitation during week 6 as compared to baseline
Symptom control after 6 weeks of treatment
Secondary Outcomes (1)
Health Related Quality of Life
end of study
Study Arms (3)
Rabeprazole morning/evening placebo bedtime
PLACEBO COMPARATORAciPhex 20 mg BID and once daily placebo
Rabeprazole breakfast, placebo dinner and bedtime
PLACEBO COMPARATORAcipHex 20 mg once daily and BID placebo
Rabeprazole breakfast, placebo dinner, nortriptyline bedtime
ACTIVE COMPARATORAcipHex 20 mg once daily, placebo once daily and nortriptyline once daily
Interventions
Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime
Breakfast \& Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime
Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime
Eligibility Criteria
You may qualify if:
- Currently being treated with a PPI, but continue to experience GERD symptoms (such as heartburn) at least 2 times per week.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Recruitment challenges, including difficulty finding patients who "fail" PPI but had not already been prescribed doubled dose. Necessitated a no-cost extension to complete recruitment
Results Point of Contact
- Title
- Christopher Wendel, MS
- Organization
- Southern Arizona VA Health Care System
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2007
First Posted
October 4, 2007
Study Start
April 1, 2006
Primary Completion
April 1, 2010
Study Completion
November 1, 2011
Last Updated
August 18, 2014
Results First Posted
August 18, 2014
Record last verified: 2014-07