MedTrace Logo

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

NCT00658775 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1069

Last updated 2015-12-21

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

DRUG

Rabeprazole sodium

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

DRUG

Esomeprazole

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

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Yufang Lu · 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
  • Lithuania

Study Locations

More Related Trials

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 NCT00658775 on ClinicalTrials.gov