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

NCT ID: NCT00859287

Last Updated: 2009-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10703 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Reflux Esophagitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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AstraZeneca Japan Medical Director MD

Role: STUDY_DIRECTOR

AstraZeneca

References

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Yoshida S, Nii M, Date M. Effects of omeprazole on symptoms and quality of life in Japanese patients with reflux esophagitis: final results of OMAREE, a large-scale clinical experience investigation. BMC Gastroenterol. 2011 Feb 28;11:15. doi: 10.1186/1471-230X-11-15.

Reference Type DERIVED
PMID: 21356058 (View on PubMed)

Other Identifiers

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NIS-GJP-DUM-2007/1

Identifier Type: -

Identifier Source: org_study_id

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