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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00768196
Other study ID # NIS-GKR-DUM-2008/1
Secondary ID
Status Completed
Phase N/A
First received October 1, 2008
Last updated December 6, 2010
Start date September 2008
Est. completion date February 2009

Study information

Verified date December 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date February 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- GERD patients who have experienced heartburn or acid regurgitation during past 7 days

- GERD patients who have already undergone endoscopy before enrolment

Exclusion Criteria:

- Involvement in the planning and conduct of the programme

- The person who took the medicine such as PPI or H2RA during the last 7 days

- Severe systemic disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
Korea, Republic of Research Site Cheonan Chungnam
Korea, Republic of Research Site Seoul Kyungkido
Korea, Republic of Research Site Sungnam Kyungkido
Korea, Republic of Research Site Suwon Kyungkido

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary variable is the total rate of GERD patients who had EED symptom and effect on their quality of life.
Secondary The secondary variable is the comparison of the EED symptom frequency in ERD and NERD patients.
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