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

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

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

NCT00658632•Eisai Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, ages 18 to 75 years.
•2. History of gastroesophageal reflux disease (GERD) symptoms for at least 3 months immediately before screening.
•3. Heartburn for at least 2 days a week for at least 1 month before screening.
•4. Esophageal erosions of Los Angeles (LA) Grades A or B based on EGD taken within 14 days prior to enrollment.
•5. Subjects who are H. pylori negative based on a screening test.
•6. Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception.
•7. Subjects must be able to read, write, and understand the language of the symptom diary.

Exclusion Criteria

•1. Current or a history of esophageal motility disorders.
•2. Current or a history of Barrett's esophagus. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).
•3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
•4. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
•5. Inflammatory bowel disease.
•6. Unstable diabetes mellitus.
•7. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
•8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\>=20 mg/day prednisone or equivalent), or aspirin (\> 325 mg/day).

Locations (85)

Huntsville, Alabama, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Sherwood, Arkansas, United States

Anaheim, California, United States

Chula Vista, California, United States

Fullerton, California, United States

Irvine, California, United States

Laguna Hills, California, United States

Key Dates

Start Date

February 1, 2008

Primary Completion Date

April 1, 2009

Completion Date

September 1, 2009

Last Updated

May 4, 2016

Enrollment

1,397

ACTUAL participants

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

Rabeprazole sodium

DRUG

Esomeprazole

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 4, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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