Retrospective Observational Study on GERD Management in General Hospitals in Korea

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD)

• Registration Number: NCT06974903
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

A RetrospectiVe ObservatIoNal Study of a CurrEnt Status and its Management of GERD (GastroEsophageal Reflux Disease) in General HOspitals in Korea

Detailed Description

This study is designed as a multicenter, retrospective observational study. After signing a contract with the research institution or investigator, patients who meet the inclusion/exclusion criteria in the study protocol will be enrolled. The registration of patients at each research site will be carried out in order based on the most recent visit date (or GERD diagnosis date) as of January 1, 2018. Data from the study subjects will be collected by reviewing medical records from January 1, 2018, to August 31, 2020. These data will be recorded in the eCRF through interviews, examinations, and tests performed under the investigator's judgment during routine clinical practice within this period.

Study Timeline

• Study Start: 2018-01-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13750

Inclusion Criteria

1. Patients aged 19 years or older as of the date of their first visit.
2. Patients who visited domestic general hospitals (secondary and tertiary healthcare institutions) at least twice between January 1, 2018, and August 31, 2020, for the diagnosis or treatment of GERD.

Exclusion Criteria

1. Patients with no GERD treatment information recorded in the medical records, even once.
2. Patients deemed inappropriate for participation by the investigator (e.g., when the overall GERD diagnosis/treatment information is missing from the medical records).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of Incidence of Adverse events following the administration of GERD treatment medications	From enrollment to 2 years and 7 months after registration	the safety assessment of all adverse events occurring after GERD medication treatment

Trial Locations

Locations (1)

Hanyang University Hospital; 🇰🇷 Seoul, Seongdong-gu, Korea, Republic of