Gastroesophageal Reflux Disease
Conditions
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).
Interventions
DRUGFexuprazan
Fexuclue Tablet 40mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average score change in RDQ | 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
| Measure | Time frame | Description |
|---|---|---|
| changes in average score of the individual symptoms (reflux, heartburn, indigestion) | 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) from baseline (0\ 5) |
| RDQ validity rate | At least 2 weeks (up to 8 weeks) | RDQ validity rate at least 2 weeks(up to 8 weeks) from baseline |
| Overall improvement evaluated by the subjects | At least 2 weeks (up to 8 weeks) | Overall improvement result (scale 1\ 5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the subjects at least 2 weeks(up to 8 weeks) from baseline |
| Overall improvement evaluated by the researchers | At least 2 weeks (up to 8 weeks) | Overall improvement (scale 1\ 5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the researchers at least 2 weeks(up to 8 weeks) from baseline |
Countries
South Korea
Outcome results
None listed