A Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab. in Patients With Erosive Gastroesophageal Reflux Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10,067
- Locations
- 1
- Primary Endpoint
- Average score change in RDQ
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult aged 19 years to 75 years (on registration date)
- •Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.
- •Patient who agreed to participate in this observation study and signed Informed Consent Form
Exclusion Criteria
- •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
- •A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;
- •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
Arms & Interventions
Treatment group
treated with Fexuclue Tablet 40mg
Intervention: Fexuprazan (Drug)
Outcomes
Primary Outcomes
Average score change in RDQ
Time Frame: At least 2 weeks (up to 8 weeks)
Average score change in RDQ at least 2 weeks (up to 8 weeks) compared to baseline
Secondary Outcomes
- RDQ validity rate(At least 2 weeks (up to 8 weeks))
- changes in average score of the individual symptoms (reflux, heartburn, indigestion)(At least 2 weeks (up to 8 weeks))
- Overall improvement evaluated by the subjects(At least 2 weeks (up to 8 weeks))
- Overall improvement evaluated by the researchers(At least 2 weeks (up to 8 weeks))