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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | treated with Fexuclue Tablet 40mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fexuprazan | Drug | Fexuclue Tablet 40mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average score change in RDQ | Average score change in RDQ at least 2 weeks (up to 8 weeks) compared to baseline | At least 2 weeks (up to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| changes in average score of the individual symptoms (reflux, heartburn, indigestion) | changes in average score of the individual symptoms (reflux, heartburn, indigestion) at least 2 weeks(up to 8 weeks) from baseline (0~5) | At least 2 weeks (up to 8 weeks) |
| RDQ validity rate |
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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 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
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The study population was calculated by the average of changes and standard deviation at two weeks and by referring to Michael Shaw et al. (2008)'s RDQ score (reverse flow, heartburn, indigestion)
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| Name | Affiliation | Role |
|---|---|---|
| Seungyoung Seo | Jeonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk National University Hospital | Jeonju | South Korea |
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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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| ID | Term |
|---|---|
| C000634065 | fexuprazan |
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RDQ validity rate at least 2 weeks(up to 8 weeks) from baseline |
| At least 2 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 least 2 weeks(up to 8 weeks) from baseline | At least 2 weeks (up to 8 weeks) |
| Overall improvement evaluated by the researchers | 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 | At least 2 weeks (up to 8 weeks) |
| D004066 | Digestive System Diseases |