NCT01391715

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Inje University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	rabeprazole	rabeprazole 20mg bid per day for 2 weeks
DRUG	standard dose rabeprazole	rabeprazole 20mg qd per day for 2 weeks

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2011-07-12
• Last updated: 2012-01-18

Locations

1 site across 1 country: South Korea