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This study aims to evaluate the efficacy of Fexuclue tablets in improving gastrointestinal symptoms based on patient-reported outcomes (PROs), by comparing assessments before and after treatment.
In this observational study, patient-reported data will be collected using an electronic application (e-PRO). The survey on subjective symptoms will be administered twice-once before and once after the administration of Fexuclue tablets. Additionally, a survey on medication convenience will be conducted once at 2 weeks (up to a maximum of 4 weeks) post-administration.
At the same time point (2 to 4 weeks after administration), patients will self-assess their overall improvement through the e-PRO application. Investigators will also evaluate final improvement based on clinical judgment in a real-world setting and record the outcome in the Case Report Form (CRF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fexuclue® Tab | Fexuclue® Tab Fexuclue® Tab Fexuprazan Hydrochloride 10mg |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with improvement in subjective symptoms | The proportion of subjects with improvement in subjective symptoms at Week 2 (up to Week 4) compared to baseline. | 2 weeks(up to 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the mean frequency scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (daily) | Change from baseline in the mean frequency scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (daily) at 2 weeks(up to 4 weeks) | 2 weeks(up to 4 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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The proportion of subjects with improved subjective symptoms at 2 to 4 weeks after Fexuclue tablet administration for gastritis will be assessed based on patient-reported outcomes. Referring to prior Phase 3 data, a 60% efficacy rate is assumed. Using G-Power 3.1.9.7 with a two-sided significance level of 0.05 and statistical power of 95%, the minimum sample size was calculated to be 10,434. Considering a 25% dropout rate, approximately 13,000 participants will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| So Heui Kim | Contact | 82-10-2994-5887 | 2210325@daewoong.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jingun Kim, Dr. | Masong Kim Internal Medicine Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masong Kim Internal Medicine Clinic | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D005756 | Gastritis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| Change from baseline in the mean severity scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (very severe) | Change from baseline in the mean severity scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (very severe) at 2 weeks(up to 4 weeks) | 2 weeks(up to 4 weeks) |
| Disappearance rate of subjective symptoms | Disappearance rate of subjective symptoms at 2 weeks(up to 4 weeks) | 2 weeks(up to 4 weeks) |
| Overall improvement assessed at each time point by both the subject and the investigator using the Final Improvement Assessment, which consists of a 5-point scale ranging from 'fully recovered' to 'worsened' | Overall improvement assessed at each time point by both the subject and the investigator using the Final Improvement Assessment, which consists of a 5-point scale ranging from 'fully recovered' to 'worsened' at 2 weeks(up to 4 weeks) | 2 weeks(up to 4 weeks) |
| Patient-reported satisfaction with medication intake convenience assessed at Week 2 (up to Week 4) compared to baseline, using a 5-point scale ranging from 'very convenient' to 'very inconvenient' | Patient-reported satisfaction with medication intake convenience assessed at Week 2 (up to Week 4) compared to baseline, using a 5-point scale ranging from 'very convenient' to 'very inconvenient' at 2 weeks(up to 4 weeks) | 2 weeks(up to 4 weeks) |
| D000092124 |
| Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |