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

Inje University

Status and phase: Withdrawn; Phase 3

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: rabeprazole; Drug: standard dose rabeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01391715

01July2011

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Double dose rabeprazole

Active Comparator group

Description:

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

Treatment:

Drug: rabeprazole

standard dose rabeprazole

Placebo Comparator group

Description:

rabeprazole 20mg per day will bi given for 2 weeks

Treatment:

Drug: standard dose rabeprazole