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

AstraZeneca10,703 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

10,703

Conditions

Reflux Esophagitis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Patients symptom evaluated by investigator

Time frame: at entry, 4 weeks and 8 weeks

Patients reported symptom

Time frame: at entry, 4 weeks and 8 weeks

Secondary Outcomes

Patients reported outcome score

Time frame: at entry, 4 weeks and 8 weeks

Adverse event

Time frame: 8 weeks

Data from ClinicalTrials.gov

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