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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00859287
Acronym
OMAREE
Enrollment
10703
Registered
2009-03-11
Start date
2007-06-30
Completion date
2008-07-31
Last updated
2009-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux Esophagitis

Keywords

Reflux esophagitis, Omepral®, QOLRAD

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.

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frame
Patients symptom evaluated by investigatorat entry, 4 weeks and 8 weeks
Patients reported symptomat entry, 4 weeks and 8 weeks

Secondary

MeasureTime frame
Patients reported outcome scoreat entry, 4 weeks and 8 weeks
Adverse event8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026