Clincosm LogoSign in Get a demo

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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00859287
Collaborator
(none)
10,703
Enrollment
13
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    10703 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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
    Study Start Date :
    Jun 1, 2007
    Actual Study Completion Date :
    Jul 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. Patients symptom evaluated by investigator [at entry, 4 weeks and 8 weeks]

    2. Patients reported symptom [at entry, 4 weeks and 8 weeks]

    Secondary Outcome Measures

    1. Patients reported outcome score [at entry, 4 weeks and 8 weeks]

    2. Adverse event [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: AstraZeneca Japan Medical Director MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00859287
    Other Study ID Numbers:
    • NIS-GJP-DUM-2007/1
    First Posted:
    Mar 11, 2009
    Last Update Posted:
    Jul 15, 2009
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    Reflux esophagitis
    Omepral®
    QOLRAD
    Additional relevant MeSH terms:
    Esophagitis
    Esophagitis, Peptic

    Study Results

    No Results Posted as of Jul 15, 2009