Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD)
• Interventions: Drug: Rabeprazole sodium; Drug: Esomeprazole

• Registration Number: NCT00658632
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).

Detailed Description

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of mild to moderate erosive Gastroesophageal Reflux Disease (GERD).

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-09
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-15
• Primary Completion: 2009-04
• Study Completion: 2009-09
• Results First Submitted: 2015-06-08
• Results First Submitted QC: 2015-06-08
• Results First Posted: 2015-06-23
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1397

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rabeprazole sodium	-
2	Esomeprazole	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks	Baseline and Week 8	Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).; Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.; Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.; Gread D: Mucosal breaks involving at least 75% of the esophageal circumference.
Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks	Baseline and Week 4	Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).; Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.; Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.; Gread D: Mucosal breaks involving at least 75% of the esophageal circumference.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4	Week 4	During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.