Clinical trial NCT06948487: Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis
Official title: A Prospective, Multi-center, Observational Study on the Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastritis
Keywords: Acute
Chronic
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2025-04-29
Enrollment: 12000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of subjects with improvement in subjective symptoms
timeFrame: 2 weeks(up to 4 weeks)
Secondary outcomes:
measure: 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)
timeFrame: 2 weeks(up to 4 weeks)
measure: 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)
timeFrame: 2 weeks(up to 4 weeks)
measure: Disappearance rate of subjective symptoms
timeFrame: 2 weeks(up to 4 weeks)
measure: 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'
timeFrame: 2 weeks(up to 4 weeks)
measure: 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'
timeFrame: 2 weeks(up to 4 weeks)
Other outcomes:
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