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Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients (Preedom)
This study is not yet open for participant recruitment.
Verified by AstraZeneca, October 2008
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00768196
  Purpose

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.


Condition
Gastroesophageal Reflux Disease

MedlinePlus related topics: GERD
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The primary variable is the total rate of GERD patients who had EED symptom and effect on their quality of life.

Secondary Outcome Measures:
  • The secondary variable is the comparison of the EED symptom frequency in ERD and NERD patients.

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 2000
Study Start Date: October 2008
Estimated Study Completion Date: January 2009
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

general hospital sample

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768196

Contacts
Contact: AstraZeneca Korea Clinical Study Information +82-2-2188-0145 soyoung.an@astrazeneca.com

Locations
Korea, Republic of, Bundang
Research Site
Sungnam, Bundang, Korea, Republic of
Korea, Republic of, Dongjak
Research Site
Seoul, Dongjak, Korea, Republic of
Korea, Republic of, Dongnam
Research Site
Chunan, Dongnam, Korea, Republic of
Korea, Republic of, Jungu
Research Site
Incheon, Jungu, Korea, Republic of
Korea, Republic of, Kangnam-Gu
Research Site
Seoul, Kangnam-Gu, Korea, Republic of
Korea, Republic of, Paldang
Research Site
Suwon, Paldang, Korea, Republic of
Korea, Republic of, Songpa-Gu
Research Site
Seoul, Songpa-Gu, Korea, Republic of
Korea, Republic of, Sungdong
Research Site
Seoul, Sungdong, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joon-Woo Bahn AstraZeneca Korea
  More Information

Study ID Numbers: NIS-GKR-DUM-2008/1
Study First Received: October 1, 2008
Last Updated: October 7, 2008
ClinicalTrials.gov Identifier: NCT00768196  
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
GERD
Korea
typical symptom
quality of life
Naturalistic
epidemiological

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Quality of Life
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on January 15, 2009