Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

May 24, 2023 updated by: Daewoong Pharmaceutical Co. LTD.

A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet in Patients With Erosive Gastroesophageal Reflux Disease

This observational study is a large-scale, prospective, and multi-institutional observational study.

Patients from 19 to 75 years of age, will take a self-assessment (PRO) during the study period before and after administration of Pexuclue tablet.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Data will be collected based on patient's medical records from daily visit. Enrolled subjects will take a Patient Reported Outcome (PRO) survey including Quality of life evaluation (GERD-HRQL) and self-awareness symptom (RDQ).

The survey will be done twice (before and after the administration of Fexuclue tablet) electronically through an application (e-PRO).

Study Type

Observational

Enrollment (Estimated)

18000

Contacts and Locations

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

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Co&Ping Otolaryngology Clinic
        • Contact:
          • Homin Lee

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

Probability Sample

Study Population

Referring to the minimum number of subjects required and the number of patients with gastroesophageal reflux disease in Korea, We expected to recruit about 16,000 people which is 0.2 %.

However, since this study is conducted under daily medical care, we expected 10% to be dropout rate.

Therefore the total study population is about 18,000

Description

Inclusion Criteria:

  1. Adult aged 19 years to 75 years (on registration date)
  2. Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.
  3. Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
  4. Patient who agreed to participate in this observation study and signed Informed Consent Form

Exclusion Criteria:

  1. A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet

    • Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof
    • Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations
    • Pregnant and lactating women
    • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
  2. A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
  3. In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average score change
Time Frame: at 0 weeks (up to 3 days)
Average score change in Reflux Disease Questionnaire
at 0 weeks (up to 3 days)
Average score change
Time Frame: at least 4 weeks (up to 8 weeks)
Average score change in Reflux Disease Questionnaire
at least 4 weeks (up to 8 weeks)

Collaborators and Investigators

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

Sponsor

Daewoong Pharmaceutical Co. LTD.

Investigators

  • Principal Investigator: Homin Lee, Co&Ping Otolaryngology Clinic

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)

May 22, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Estimated)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DWFE_P407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided at this point

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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