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

Last updated: July 14, 2025
Sponsor: Daewoong Pharmaceutical Co. LTD.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-ulcer Dyspepsia (Nud)

Stomach Discomfort

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT06948487
DW_FEX_DB_03
  • Ages 19-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult subjects between the ages of 19 and 75 years at the time of obtaining writteninformed consent.

  • Subjects who are scheduled to receive Fexuclu tablets (fexuprazan) in accordancewith the approved indication.

  • Subjects who present with at least one subjective symptom requiring medicaltreatment

  • Subjects who are capable of understanding the information provided, have voluntarilydecided to participate in this observational study, and have provided writteninformed consent for the use of their personal data.

Exclusion

Exclusion Criteria:

  • Individuals who fall under any contraindications for the administration of Fexuclutablets (fexuprazan) as specified in the approved labeling.

  • Individuals who are deemed by the investigator (attending physician) to beinappropriate for participation in this observational study for any reason nototherwise specified.

Study Design

Total Participants: 12000
Study Start date:
June 17, 2025
Estimated Completion Date:
June 03, 2027

Study 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).

Connect with a study center

  • Masong Kim Internal Medicine Clinic

    Seoul,
    Korea, Republic of

    Active - Recruiting

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