Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD)
• Interventions: Drug: Rabeprazole ER; Drug: Ranitidine

• Registration Number: NCT00839306
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to compare the efficacy of rabeprazole extended release 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive gastroesophageal reflux disease (eGERD).

Detailed Description

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily).

Please note that this study is not a duplicate of E3810-G000-305; this is a separate study being conducted along with -305.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Primary Completion: 2009-08
• Study Completion: 2010-01
• Results First Submitted: 2015-06-08
• Results First Submitted QC: 2015-10-15
• Results First Posted: 2015-11-16
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rabeprazole ER	-
2	Ranitidine	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26	Baseline to Week 26	eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal 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.; Grade D: Mucosal breaks involving at least 75% of the esophageal circumference.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26	Baseline to Week 26	Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).

Trial Locations

Locations (3)

Midwest Clinical; 🇺🇸 Moline, Illinois, United States

Associates, Ltd.; 🇺🇸 Moline, Illinois, United States

Research; 🇺🇸 Moline, Illinois, United States