MedTrace Logo

Reflux Esophagitis Phase III Study (Maintenance Treatment)

NCT00634114 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2010-06-17

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.

Conditions

  • Reflux Esophagitis

Interventions

DRUG

Esomeprazole

10mg once daily oral administration

DRUG

Esomeprazole

20mg once daily oral administration

DRUG

Omeprazole

10mg once daily oral administration

Sponsors & Collaborators

Principal Investigators

  • Maotsugu Oyama, MD, PhD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Completion
2009-05-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

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 NCT00634114 on ClinicalTrials.gov