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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Double dose rabeprazole

Rabeprazole 20m bid per day will be given for 2 weeks

Group Type ACTIVE_COMPARATOR

rabeprazole

Intervention Type DRUG

rabeprazole 20mg bid per day for 2 weeks

standard dose rabeprazole

rabeprazole 20mg per day will bi given for 2 weeks

Group Type PLACEBO_COMPARATOR

standard dose rabeprazole

Intervention Type DRUG

rabeprazole 20mg qd per day for 2 weeks

Interventions

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rabeprazole

rabeprazole 20mg bid per day for 2 weeks

Intervention Type DRUG

standard dose rabeprazole

rabeprazole 20mg qd per day for 2 weeks

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No