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

September 30, 2013 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

855

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Research Site
      • Daegu, Korea, Republic of
        • Research Site
      • Daejeon, Korea, Republic of
        • Research Site
      • Gangneung, Korea, Republic of
        • Research Site
      • Goyang-si, Korea, Republic of
        • Research Site
      • Gwangju, Korea, Republic of
        • Research Site
      • Incheon, Korea, Republic of
        • Research Site
      • Jeonju-si, Korea, Republic of
        • Research Site
      • Seongnam-si, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with typical reflux symptoms (heartburn or regurgitation) undergone upper endoscopy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Typical reflux symptom by EGD
Total 2000 subjects who has Typical reflux symptom by EGD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of recurrence after treatment with PPI in patients with GERD
Time Frame: 12month
12month
Response rate to the treatment with PPI in patients with GERD
Time Frame: 12month
12month

Secondary Outcome Measures

Outcome Measure
Time Frame
Baseline characteristics related to the recurrence of GERD
Time Frame: 12month
12month
Rate of complete resolution in each group of patients with ERD or NERD
Time Frame: 12month
12month
Rate of recurrence in each group of patients with ERD or NERD
Time Frame: 12month
12month
Quality of life measured by EQ-5D and WPAI-GERD in each group of patients with ERD or NERD
Time Frame: 12month
12month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: HyeWon Koo, AstraZeneca Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 22, 2011

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 30, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GKR-ATC-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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