We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01378338
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
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

Study Type : Observational
Actual Enrollment : 855 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational Study
Study Start Date : June 2012
Primary Completion Date : September 2013
Study Completion Date : September 2013
Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Rate of recurrence after treatment with PPI in patients with GERD [ Time Frame: 12month ]
  2. Response rate to the treatment with PPI in patients with GERD [ Time Frame: 12month ]

Secondary Outcome Measures :
  1. Baseline characteristics related to the recurrence of GERD [ Time Frame: 12month ]
  2. Rate of complete resolution in each group of patients with ERD or NERD [ Time Frame: 12month ]
  3. Rate of recurrence in each group of patients with ERD or NERD [ Time Frame: 12month ]
  4. Quality of life measured by EQ-5D and WPAI-GERD in each group of patients with ERD or NERD [ Time Frame: 12month ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with typical reflux symptoms (heartburn or regurgitation) undergone upper endoscopy
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378338


Locations
Korea, Republic of
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: HyeWon Koo AstraZeneca Korea
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01378338     History of Changes
Other Study ID Numbers: NIS-GKR-ATC-2011/1
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by AstraZeneca:
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

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes