Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

NCT ID: NCT05886933

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9846 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2024-12-31

Brief 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.

Detailed 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).

Conditions

Gastroesophageal Reflux Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Fexuprazan Hydrochloride

Patient treated with Fexuprazan Hydrochloride (Fexuclue Tablet)

Intervention Type: DRUG

Other Intervention Names

Fexuclue Tablet

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Homin Lee

Role: PRINCIPAL_INVESTIGATOR

Co&Ping Otolaryngology Clinic

Locations

Co&Ping Otolaryngology Clinic

Busan, , South Korea

Countries

South Korea

Other Identifiers

DWFE_P407

Identifier Type: -

Identifier Source: org_study_id