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Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

Non Recruiting
19-75 years
All
Phase N/A

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Overview

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.

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).

Eligibility

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 details
    Gastroesophageal Reflux Disease

NCT05886933

Daewoong Pharmaceutical Co. LTD.

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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