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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10067 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-06

Study Completion Date

2024-11-08

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment group

treated with Fexuclue Tablet 40mg

Fexuprazan

Intervention Type DRUG

Fexuclue Tablet 40mg

Interventions

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Fexuprazan

Fexuclue Tablet 40mg

Intervention Type DRUG

Eligibility Criteria

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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 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 participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;
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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No