Phase 3
N=168
Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT00539240 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better) — 6.6; 5.9; 6.1 days — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 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)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better) |
6.6; 5.9; 6.1 | 0.04 sig |
| PRIMARY Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline |
6.6; 5.8; 6.0 | 0.04 sig |
| PRIMARY Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better) |
6.7; 5.9; 6.3 | 0.04 sig |
| SECONDARY Health Related Quality of Life |
42.0; 37.7; 37.7 | 0.19 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00539240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.