Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab

Last updated: January 22, 2025
Sponsor: Daewoong Pharmaceutical Co. LTD.
Overall Status: Completed

Phase

N/A

Condition

Heartburn (Pediatric)

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Treatment

Fexuprazan

Clinical Study ID

NCT05614752
DWFE_P406
  • Ages 19-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ofinvestigator.

  3. Patient who agreed to participate in this observation study and signed InformedConsent Form

Exclusion

Exclusion Criteria:

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

  • Patients with hypersensitivity to the components of Fexuclue tablet or Fexucluetablet and a history thereof

  • Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containingpreparations

  • Pregnant and lactating women

  • Patients with genetic problems such as galactose intolerance, Lapp lactasedeficiency, or glucose-galactose malabortion

  1. A person who participates in another clinical trial and is administering (applying)clinical trial drugs or clinical trial medical devices;

  2. In addition to the above, a person who has determined that the researcher (thedoctor in charge) is not suitable for participation in this observation study

Study Design

Total Participants: 10067
Treatment Group(s): 1
Primary Treatment: Fexuprazan
Phase:
Study Start date:
July 06, 2022
Estimated Completion Date:
November 08, 2024

Study 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).

Connect with a study center

  • Jeonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Site Not Available

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