Omepral® Tablets Special Clinical Experience Investigation in Patients With Erosive Esophagitis (OMAREE)

July 14, 2009 updated by: AstraZeneca

Omepral® Tablets Mega-study to Investigate the Efficacy on Various Type of Acid Reflux Related Symptoms and QOL, and Epidemiology in Patients With Erosive Esophagitis in Daily Medical Practice

This open label, non-interventional study is to compare the efficacy of Omepral® tablet and any other treatments excepting proton pump inhibitors (PPIs) for the treatment of various type of acid reflux related symptoms in patients with reflux esophagitis.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients endoscopically diagnosed as erosive esophagitis accompanied with either two days or more heartburn or acid taste in the mouth of any severity

Description

Inclusion Criteria:

  • Patients newly diagnosed as erosive esophagitis or history of erosive esophagitis confirmed by endoscopy.
  • Patients who answered questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
  • During the past 1 week , patients who have either two days or more with heartburn or acid taste in the mouth of any severity

Exclusion Criteria:

  • Patients receiving treatment with proton pump inhibitors, which make stomach acid decreased during the last 4 weeks prior to enrolment.
  • Patients who cannot answer questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
  • Patients included previously in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients symptom evaluated by investigator
Time Frame: at entry, 4 weeks and 8 weeks
at entry, 4 weeks and 8 weeks
Patients reported symptom
Time Frame: at entry, 4 weeks and 8 weeks
at entry, 4 weeks and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients reported outcome score
Time Frame: at entry, 4 weeks and 8 weeks
at entry, 4 weeks and 8 weeks
Adverse event
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Japan Medical Director MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Estimate)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GJP-DUM-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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