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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00859287
Other study ID # NIS-GJP-DUM-2007/1
Secondary ID
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
Est. primary completion date
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


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
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