Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD: a Randomized Controlled Trial

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: rabeprazole
* Drug: standard dose rabeprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Double dose rabeprazole<br>Rabeprazole 20m bid per day will be given for 2 weeks | Drug: rabeprazole<br>* rabeprazole 20mg bid per day for 2 weeks<br>|
| Placebo Comparator: standard dose rabeprazole<br>rabeprazole 20mg per day will bi given for 2 weeks | Drug: standard dose rabeprazole<br>* rabeprazole 20mg qd per day for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom improvement at 2 week after double dose rabeprazole treatment | symptom improvement according to FSSG(the frequency scale for the symptoms of GERD) at 2 week after double dose rabeprazole treatment | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained symptom improvement at 6 week after treatment | sustained symptom improvement assessed by FSSG(the frequency scale for the symptoms of GERD)score at 6 week after treatment | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal reflux disease, Proton pump inhibitor, standard dose, Double dose