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

Completed

• Conditions: 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

• Registration Number: NCT01378338
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-22
• Study Start: 2012-06
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 855

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of recurrence after treatment with PPI in patients with GERD	12month
Response rate to the treatment with PPI in patients with GERD	12month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of