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Recruiting NCT06948487

Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis

Observational Gastritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Gastritis. Basic parameters: 19 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective, Multi-center, Observational Study on the Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis

Overview

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).

Primary outcome measures

  • The proportion of subjects with improvement in subjective symptoms [Time frame: 2 weeks(up to 4 weeks)]
Secondary outcome measures (5)
  • 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) [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) [Time frame: 2 weeks(up to 4 weeks)]
  • Disappearance rate of subjective symptoms [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' [Time frame: 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' [Time frame: 2 weeks(up to 4 weeks)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

South Korea · 1 center
  • Masong Kim Internal Medicine Clinic — Seoul

Identifiers

NCT: NCT06948487 · DW_FEX_DB_03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗