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

Daewoong Pharmaceutical

Status: Begins enrollment this month

Conditions: Gastritis

Study type: Observational

Funder types: Industry

Identifiers

NCT06948487

DW_FEX_DB_03

Details and patient eligibility

About

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.

Full 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).

Enrollment: 12,000 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

12,000 participants in 1 patient group

Fexuclue® Tab

Description:

Fexuclue® Tab Fexuclue® Tab Fexuprazan Hydrochloride 10mg