Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis
ConditionGastritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-75
SponsorDaewoong Pharmaceutical Co. LTD.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
12,000 Participants
are grouped into 1 trial groupGroup A: Fexuclue® Tab
Trial outcomes
Primary outcomes
1
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.
Time frame
2 weeks(up to 4 weeks)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov