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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01378338
First received: May 24, 2011
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition
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 Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Rate of recurrence after treatment with PPI in patients with GERD [ Time Frame: 12month ] [ Designated as safety issue: No ]
  • Response rate to the treatment with PPI in patients with GERD [ Time Frame: 12month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Baseline characteristics related to the recurrence of GERD [ Time Frame: 12month ] [ Designated as safety issue: No ]
  • Rate of complete resolution in each group of patients with ERD or NERD [ Time Frame: 12month ] [ Designated as safety issue: No ]
  • Rate of recurrence in each group of patients with ERD or NERD [ Time Frame: 12month ] [ Designated as safety issue: No ]
  • Quality of life measured by EQ-5D and WPAI-GERD in each group of patients with ERD or NERD [ Time Frame: 12month ] [ Designated as safety issue: No ]

Estimated Enrollment: 855
Study Start Date: June 2012
Estimated Study Completion Date: September 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Typical reflux symptom by EGD
Total 2000 subjects who has Typical reflux symptom by EGD

  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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01378338     History of Changes
Other Study ID Numbers: NIS-GKR-ATC-2011/1
Study First Received: May 24, 2011
Last Updated: March 21, 2013
Health Authority: Korea: Food and Drug Administration

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:
Gastroesophageal Reflux
Recurrence
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013