NCT05614752

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

A Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab. in Patients With Erosive Gastroesophageal Reflux Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,067 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Fexuprazan	Fexuclue Tablet 40mg

Timeline

• Start date: 2022-07-06
• Primary completion: 2023-12-31
• Completion: 2024-11-08
• First posted: 2022-11-14
• Last updated: 2025-01-24

Locations

1 site across 1 country: South Korea