Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

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

Phase

N/A

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

Fexuprazan Hydrochloride

Clinical Study ID

NCT05886933
DWFE_P407
  • 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 has not taken a treatment for gastroesophageal reflux disease within twoweeks from baseline visit.

  4. 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 has taken a treatment for gastroesophageal reflux disease within twoweeks from baseline visit.

  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: 9846
Treatment Group(s): 1
Primary Treatment: Fexuprazan Hydrochloride
Phase:
Study Start date:
May 22, 2023
Estimated Completion Date:
December 31, 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

  • Co&Ping Otolaryngology Clinic

    Busan,
    Korea, Republic of

    Site Not Available

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