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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexuprazan Hydrochloride | Drug | Patient treated with Fexuprazan Hydrochloride (Fexuclue Tablet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | at least 4 weeks (up to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in average score of the degree by symptoms (reflux, heartburn, indigestion) | Average score change in Reflux Disease Questionnaire (0 ~5) from baseline | at least 4 weeks (up to 8 weeks) |
| Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion) |
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Inclusion Criteria:
Exclusion Criteria:
A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet
A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
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
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Referring to the minimum number of subjects required and the number of patients with gastroesophageal reflux disease in Korea, We expected to recruit about 16,000 people which is 0.2 %.
However, since this study is conducted under daily medical care, we expected 10% to be dropout rate.
Therefore the total study population is about 18,000
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| Name | Affiliation | Role |
|---|---|---|
| Homin Lee | Co&Ping Otolaryngology Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Co&Ping Otolaryngology Clinic | Busan | South Korea |
Undecided at this point
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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Average score change in Reflux Disease Questionnaire (0 ~5) from baseline |
| at least 4 weeks (up to 8 weeks) |
| RDQ validity rate | RDQ validity rate at 4 weeks(up to 8 weeks) from baseline | at least 4 weeks (up to 8 weeks) |
| RDQ loss rate | RDQ loss rate at 4 weeks(up to 8 weeks) from baseline | 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 | 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 | 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 | at least 4 weeks (up to 8 weeks) |
| D004066 | Digestive System Diseases |