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).
Study Type
OBSERVATIONAL
Enrollment
12,000
Masong Kim Internal Medicine Clinic
Seoul, South Korea
RECRUITINGThe 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.
Time frame: 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)
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)
Time frame: 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)
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)
Time frame: 2 weeks(up to 4 weeks)
Disappearance rate of subjective symptoms
Disappearance rate of subjective symptoms at 2 weeks(up to 4 weeks)
Time frame: 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)
Time frame: 2 weeks(up to 4 weeks)
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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)
Time frame: 2 weeks(up to 4 weeks)