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.
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 Type
OBSERVATIONAL
Enrollment
9,846
Patient treated with Fexuprazan Hydrochloride (Fexuclue Tablet)
Co&Ping Otolaryngology Clinic
Busan, South Korea
Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)
Average score change in Reflux Disease Questionnaire (0 \~5) from baseline
Time frame: at least 4 weeks (up to 8 weeks)
Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)
Average score change in Reflux Disease Questionnaire (0 \~5) from baseline
Time frame: at least 4 weeks (up to 8 weeks)
Changes in average score of the degree by symptoms (reflux, heartburn, indigestion)
Average score change in Reflux Disease Questionnaire (0 \~5) from baseline
Time frame: at least 4 weeks (up to 8 weeks)
Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion)
Average score change in Reflux Disease Questionnaire (0 \~5) from baseline
Time frame: at least 4 weeks (up to 8 weeks)
RDQ validity rate
RDQ validity rate at 4 weeks(up to 8 weeks) from baseline
Time frame: at least 4 weeks (up to 8 weeks)
RDQ loss rate
RDQ loss rate at 4 weeks(up to 8 weeks) from baseline
Time frame: at least 4 weeks (up to 8 weeks)
Overall improvement evaluated by the subjects
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
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Time frame: at least 4 weeks (up to 8 weeks)
Overall improvement evaluated by the researchers
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
Time frame: at least 4 weeks (up to 8 weeks)
Quality of Life (GERD-HRQL) Total score change
Quality of Life (GERD-HRQL) Total score change at 4 weeks(up to 8 weeks) from baseline
Time frame: at least 4 weeks (up to 8 weeks)