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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 8
Awards & highlights
Study 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).
Eligible Conditions
- Acid Reflux
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
Secondary outcome measures
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
Side effects data
From 2014 Phase 3 trial • 20 Patients • NCT0203747710%
Vomiting
10%
Pyrexia
10%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 - Vonoprazan 20 mg
Cohort 1 - Esomeprazole 20 mg
Cohort 2 - Rabeprazole Sodium 10 mg
Cohort 1 - Vonoprazan 20 mg
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
Group II: 2Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rabeprazole
FDA approved
Find a Location
Who is running the clinical trial?
Eisai Inc.Lead Sponsor
516 Previous Clinical Trials
157,495 Total Patients Enrolled
Yufang LuStudy DirectorEisai Inc.
4 Previous Clinical Trials
1,999 Total Patients Enrolled
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