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

Reflux Esophagitis Clinical Trial

— OMAREE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859287
• Other study ID #: NIS-GJP-DUM-2007/1
• Status: Completed
• Phase: N/A
• First received: March 10, 2009
• Last updated: July 14, 2009
• Start date: June 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10703
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Reflux Esophagitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients symptom evaluated by investigator		at entry, 4 weeks and 8 weeks	No
Primary	Patients reported symptom		at entry, 4 weeks and 8 weeks	No
Secondary	Patients reported outcome score		at entry, 4 weeks and 8 weeks	No
Secondary	Adverse event		8 weeks	Yes