Gastroesophageal Reflux Disease
Conditions
Keywords
Gastroesophageal reflux disease, Proton pump inhibitor, standard dose, Double dose
Brief summary
To the best of our knowledge, there has been no randomized controlled trial to compare double dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we hypothesize that a double dose PPI would accelerate and sustain the control of symptom in NERD patients.
Detailed description
In Asian, the majority of GERD cases are cases of nonerosive reflux esophagitis(NERD). NERD is a difficult -to-treat acid reflux condition even with PPI compared to reflux esophagitis(RE). In addition, the quality of life of NERD patients is quite low, NERD patients need quicker and more effective treatment options. At present, PPI-based step-down treatment is recommended for GERD patients. Doubling th PPI dose has become a commonly practiced therapeutic strategy in patients with GERD who failed PPI once daily. In patients with symptomatic GERD who failed the one dose PPI can increase the rate of overall symptom improvement by 22-26%. There are various mechanisms for standard dose PPI failure in GERD patients. Esophageal hypersensitivity is likely the underlying mechanism in a significant number of patients. Patients with the sensitive esophagus (normal endoscopy and pH test but positive symptom index) were more likely to respond to PPI twice a day. It is thus of clinical interest to determine whether an increased dosage of PPI can achieve rapidly the control of symptoms for patient with NERD patients.
Interventions
DRUGrabeprazole
rabeprazole 20mg bid per day for 2 weeks
DRUGstandard dose rabeprazole
rabeprazole 20mg qd per day for 2 weeks
Sponsors
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* heartburn and/or reflux at least twice weekly in the absence of visible esophageal mucosal breaks at endoscopy
Exclusion criteria
* pregnancy * lactation * Hx of gastric surgery * Hx of gastric cancer or peptic ulcer * major medical problems (including CHF, renal failure, COPD, asthma, liver cirrhosis) * severe systemic illness * Hx of malignancy, allergy Hx to rabeprazole * patients who had taken antibiotics * antisecretory agents including H2-blocker * PPI within 4 weeks before endoscopy * current usage of steroids, NSAIDs, aspirin, anticoagulant medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| symptom improvement at 2 week after double dose rabeprazole treatment | Two weeks | symptom improvement according to FSSG(the frequency scale for the symptoms of GERD) at 2 week after double dose rabeprazole treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sustained symptom improvement at 6 week after treatment | 6 weeks | sustained symptom improvement assessed by FSSG(the frequency scale for the symptoms of GERD)score at 6 week after treatment |
Countries
South Korea
Outcome results
None listed