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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: rabeprazole; Drug: standard dose rabeprazole

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 612-030
    • Haeundae Paik Hospital, Inje University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Inje University
• Investigators: Study Director: Tae Oh Kim, M.D. PhD., Internal Medicine, Haeundae Paik Hospital; Principal Investigator: Eun Hee Seo, M.D, Internal Medicine, Haeundae Paik Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: July 11, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): January 18, 2012
• Last Update Submitted That Met QC Criteria: January 16, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Gastroesophageal reflux disease; Proton pump inhibitor; standard dose; Double dose
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: 01July2011