Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

Daewoong Pharmaceutical

Status: Completed

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Fexuprazan Hydrochloride

Study type: Observational

Funder types: Industry

Identifiers

NCT05886933

DWFE_P407

Details and patient eligibility

About

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.

Full 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).

Enrollment: 9,846 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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