Fexuclue (fexuprazan) tablets for adults with acute or chronic gastritis — testing symptom improvement and safety.
A Prospective, Multi-center, Observational Study on the Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis
Daewoong Pharmaceutical Co. LTD. · NCT06948487
This will test whether taking Fexuclue (fexuprazan) tablets helps adults with acute or chronic gastritis feel better, using patient surveys before and 2–4 weeks after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12000 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06948487 on ClinicalTrials.gov |
What this trial studies
In this observational, real-world study, adults prescribed Fexuclue (fexuprazan) will complete electronic patient-reported outcome (e-PRO) surveys on gastrointestinal symptoms before starting the medication and again 2 to 4 weeks after administration. A separate e-PRO will collect patient-reported convenience of the medication at about 2 weeks (up to 4 weeks). Investigators will also record their clinical judgment of overall improvement in the case report form (CRF). Eligibility is limited to adults aged 19–75 who are scheduled to receive Fexuclue according to approved indications, and no experimental procedures beyond routine care are imposed.
Who should consider this trial
Good fit: Adults aged 19–75 with acute or chronic gastritis who are scheduled to start Fexuclue (fexuprazan) and have at least one symptom requiring treatment are the intended participants.
Not a fit: People with contraindications to Fexuclue, those outside the 19–75 age range, or those whose symptoms do not respond to the medication are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could show that Fexuclue improves patient-reported gastritis symptoms and is convenient to use in routine clinical practice.
How similar studies have performed: Other potassium-competitive acid blockers like vonoprazan have shown symptom and mucosal healing benefits in acid-related disorders, but real-world patient-reported outcome data specific to fexuprazan remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Masong Kim Internal Medicine Clinic — Seoul, South Korea (RECRUITING)
Study contacts
- Principal investigator: Jingun Kim, Dr. — Masong Kim Internal Medicine Clinic
- Study coordinator: So Heui Kim
- Email: 2210325@daewoong.co.kr
- Phone: 82-10-2994-5887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastritis, Acute, Chronic