Observationa Study is a Prospective and Multi-institutional Observational Study.

May 11, 2025 updated by: Jeil Pharmaceutical Co., Ltd.

Observational Study to Evaluate Effectiveness, Safety and Satisfaction Level of Zastaprazan (JAQBO®) Under Daily Treatment for Patients With Erosive Gastroesophageal Reflux Disease

This observational study is a prospective, multi-institutional non intervention study to examine the prescription patterns, corresponding treatment effects and safety in routine clinical practice for patients prescribed for the treatment of gastroesophageal reflux disease.

Study Overview

Status

Completed

Conditions

Detailed Description

The present observational study is designed to check effect and safety for patients who have been prescribed JAQBO for the treatment of erosive gastroesophageal reflux disease.

Study Type

Observational

Enrollment (Actual)

5536

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seoul, Gyeonggi-do, Korea, Republic of, 15865
        • Goodbreath Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

GERD patients

Description

Inclusion Criteria:

  1. An adult over 19 years of age
  2. A person who voluntarily provides written informed consent

Exclusion Criteria:

  1. A pregnant woman or a nursing woman
  2. A person who is deemed unsuitable for the subject of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1 cohort
No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GERD (heartburn, acid regurgitation) score in RDQ
Time Frame: 4 weeks
Scale(none / 1day / 2day/ 3-4 day / 5-6 day/ every day)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeil Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

April 23, 2025

Study Completion (Actual)

April 23, 2025

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 11, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JL-JAQ-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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