Gastroesophageal Reflux Disease (GERD)VINCERONCT06974903
Retrospective Observational Study on GERD Management in General Hospitals in Korea
An observational study of Gastroesophageal Reflux Disease (GERD), run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A RetrospectiVe ObservatIoNal Study of a CurrEnt Status and its Management of GERD (GastroEsophageal Reflux Disease) in General HOspitals in Korea Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- How many people
- 13,750 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Study population: Patients with Gastroesophageal Reflux Disease(GERD)
Who may be able to join
- Patients aged 19 years or older as of the date of their first visit.
- 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.
Who cannot join
- Patients with no GERD treatment information recorded in the medical records, even once.
- Patients deemed inappropriate for participation by the investigator (e.g., when the overall GERD diagnosis/treatment information is missing from the medical records).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RetrospectiVe ObservatIoNal Study of a CurrEnt Status and Its Management of GERD (GastroEsophageal Reflux Disease) in General HOspitals in Korea
A RetrospectiVe ObservatIoNal Study of a CurrEnt Status and its Management of GERD (GastroEsophageal Reflux Disease) in General HOspitals in Korea
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- GastroEsophageal Reflux Disease, GERD, Korean patients, Observational study, RetrospectiVe Observational study
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Incidence of Adverse events following the administration of GERD treatment medications
the safety assessment of all adverse events occurring after GERD medication treatment
Measured: From enrollment to 2 years and 7 months after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start3 Jan 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974903
- Sponsor's protocol ID
- D999_02GERD2003
- Acronym
- VINCERO
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RetrospectiVe ObservatIoNal Study of a CurrEnt Status and Its Management of GERD (GastroEsophageal Reflux Disease) in General HOspitals in Korea
- ClinicalTrials.gov ID
- NCT06974903
- Acronym / sponsor ID
- VINCERO / D999_02GERD2003
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- GastroEsophageal Reflux Disease, GERD, Korean patients, Observational study, RetrospectiVe Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,750 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Gastroesophageal Reflux Disease(GERD)
Key inclusion criteria (2 listed)
- Patients aged 19 years or older as of the date of their first visit.
- 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.
Key exclusion criteria (2 listed)
- Patients with no GERD treatment information recorded in the medical records, even once.
- Patients deemed inappropriate for participation by the investigator (e.g., when the overall GERD diagnosis/treatment information is missing from the medical records).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of Incidence of Adverse events following the administration of GERD treatment medications
Time frame: From enrollment to 2 years and 7 months after registration
the safety assessment of all adverse events occurring after GERD medication treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Related trials for Gastroesophageal Reflux Disease (GERD)
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease (GERD), run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Incidence of Adverse events following the administration of GERD treatment medications (time frame: From enrollment to 2 years and 7 months after registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.