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

Phase 3

Withdrawn

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: standard dose rabeprazole; Drug: rabeprazole

• Registration Number: NCT01391715
• Lead Sponsor: Inje University

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.

Study Timeline

• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Study Start: 2011-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard dose rabeprazole	standard dose rabeprazole	rabeprazole 20mg per day will bi given for 2 weeks
Double dose rabeprazole	rabeprazole	Rabeprazole 20m bid per day will be given for 2 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Haeundae Paik Hospital, Inje University School of Medicine; 🇰🇷 Busan, Korea, Republic of