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Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational

NCT ID: NCT01378338

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

855 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-09-30

Brief Summary

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Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD in Korea-an observational study.

Detailed Description

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Conditions

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The Aim of This Study is to Investigate the Frequency and Related Risk Factors of Recurrence, and Quality of Life in Patients With GERD After Treatment With PPI

Keywords

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GERD Comparison between ERD and NERD Rate of complete resolution rate of recurrence QOL To investigate the frequency and related risk factors of recurrence, and quality of life in patients with GERD after treatment with PPI The aim of this study is to investigate the frequency and related risk factors of recurrence, and quality of life in patients with GERD after treatment with PPI

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Typical reflux symptom by EGD

Total 2000 subjects who has Typical reflux symptom by EGD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Both ERD or NERD patient who confirmed by EGD findings within 12 months prior to V1 and have a symptom with moderate or more, at least once per week within 1 week prior to V1 and Patients between age 20 and 80with typical reflux symptoms
* Among the patient who have not taken PPI or H2 blocker within 4 weeks prior to V1, needs to be prescribed PPIs 4\~8 weeks as a part of the routine clinical practice due to typical symptom
* Patients who give the signed informed consent

Exclusion Criteria

* Patients with past history of gastrointestinal surgery
* Patients with known malignancy or history of such diseases
* Patients with moderate to severe general medical conditions like ischemic heart disease, chronic renal failure, congestive heart failure, COPD, liver cirrhosis, acute or chronic pancreatitis, or other medical conditions which the investigator considers
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HyeWon Koo

Role: STUDY_DIRECTOR

AstraZeneca Korea

Locations

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Research Site

Busan, , South Korea

Site Status

Research Site

Daegu, , South Korea

Site Status

Research Site

Daejeon, , South Korea

Site Status

Research Site

Gangneung, , South Korea

Site Status

Research Site

Goyang-si, , South Korea

Site Status

Research Site

Gwangju, , South Korea

Site Status

Research Site

Incheon, , South Korea

Site Status

Research Site

Jeonju, , South Korea

Site Status

Research Site

Seongnam-si, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NIS-GKR-ATC-2011/1

Identifier Type: -

Identifier Source: org_study_id