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

NCT00658528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1061

Last updated 2015-12-21

Study results available
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Summary

The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

DRUG

Rabeprazole sodium

Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.

DRUG

Esomeprazole

Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Yufang Lu, MD, PhD · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-09-30
Completion
2010-01-31

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Canada
  • Chile
  • Croatia
  • Estonia
  • France
  • Germany
  • Hungary
  • India
  • Latvia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00658528 on ClinicalTrials.gov