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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01378338
First received: May 24, 2011
Last updated: September 30, 2013
Last verified: September 2013

May 24, 2011
September 30, 2013
June 2012
September 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01378338 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational
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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

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

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
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Typical reflux symptom by EGD
Total 2000 subjects who has Typical reflux symptom by EGD
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
855
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01378338
NIS-GKR-ATC-2011/1
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: HyeWon Koo AstraZeneca Korea
AstraZeneca
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP