Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients - Full Text View

Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients (Preedom)

This study has been completed.

First Received on October 1, 2008. Last Updated on December 6, 2010 History of Changes

Sponsor:	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

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients

Resource links provided by NLM:

MedlinePlus related topics: GERD

U.S. FDA Resources

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.

Estimated Enrollment:	2000
Study Start Date:	September 2008
Study Completion Date:	February 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

Locations

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, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Joon-Woo Bahn

AstraZeneca Korea

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00768196 History of Changes
Other Study ID Numbers:	NIS-GKR-DUM-2008/1
Study First Received:	October 1, 2008
Last Updated:	December 6, 2010
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

GERD
Korea
typical symptom

quality of life
Naturalistic
epidemiological

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders

Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012