Gastritis
Conditions
Keywords
Acute, Chronic
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult subjects between the ages of 19 and 75 years at the time of obtaining written informed consent. * Subjects who are scheduled to receive Fexuclu tablets (fexuprazan) in accordance with the approved indication. * Subjects who present with at least one subjective symptom requiring medical treatment * Subjects who are capable of understanding the information provided, have voluntarily decided to participate in this observational study, and have provided written informed consent for the use of their personal data.
Exclusion criteria
* Individuals who fall under any contraindications for the administration of Fexuclu tablets (fexuprazan) as specified in the approved labeling. * Individuals who are deemed by the investigator (attending physician) to be inappropriate for participation in this observational study for any reason not otherwise specified.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects with improvement in subjective symptoms | 2 weeks(up to 4 weeks) | The proportion of subjects with improvement in subjective symptoms at Week 2 (up to Week 4) compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 2 weeks(up to 4 weeks) | 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) |
| 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) | 2 weeks(up to 4 weeks) | 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) |
| Disappearance rate of subjective symptoms | 2 weeks(up to 4 weeks) | Disappearance rate of subjective symptoms at 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' | 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' at 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' | 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' at 2 weeks(up to 4 weeks) |
Countries
South Korea
Contacts
Primary ContactSo Heui Kim
Outcome results
None listed