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
Patient treated with Fexuprazan Hydrochloride (Fexuclue Tablet)
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
OTHER
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ) | at least 4 weeks (up to 8 weeks) | Average score change in Reflux Disease Questionnaire (0 \ 5) from baseline |
| Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ) | at least 4 weeks (up to 8 weeks) | Average score change in Reflux Disease Questionnaire (0 \ 5) from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RDQ validity rate | at least 4 weeks (up to 8 weeks) | RDQ validity rate at 4 weeks(up to 8 weeks) from baseline |
| RDQ loss rate | at least 4 weeks (up to 8 weeks) | RDQ loss rate at 4 weeks(up to 8 weeks) from baseline |
| Changes in average score of the degree by symptoms (reflux, heartburn, indigestion) | at least 4 weeks (up to 8 weeks) | Average score change in Reflux Disease Questionnaire (0 \ 5) from baseline |
| Overall improvement evaluated by the researchers | at least 4 weeks (up to 8 weeks) | Overall improvement result (scale 1\ 5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the researchers at 4 weeks(up to 8 weeks) from baseline |
| Quality of Life (GERD-HRQL) Total score change | at least 4 weeks (up to 8 weeks) | Quality of Life (GERD-HRQL) Total score change at 4 weeks(up to 8 weeks) from baseline |
| Overall improvement evaluated by the subjects | at least 4 weeks (up to 8 weeks) | Overall improvement result (scale 1\ 5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the subjects at 4 weeks(up to 8 weeks) from baseline |
| Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion) | at least 4 weeks (up to 8 weeks) | Average score change in Reflux Disease Questionnaire (0 \ 5) from baseline |
Countries
South Korea
Outcome results
None listed