Omepral® Tablets Special Clinical Experience Investigation in Patients With Erosive Esophagitis
Completed
- Conditions
- Reflux Esophagitis
- Registration Number
- NCT00859287
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10703
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients symptom evaluated by investigator at entry, 4 weeks and 8 weeks Patients reported symptom at entry, 4 weeks and 8 weeks
- Secondary Outcome Measures
Name Time Method Patients reported outcome score at entry, 4 weeks and 8 weeks Adverse event 8 weeks