Actively Recruiting
A Prospective, Multi-center, Observational Study on the Efficacy and Safety of Fexuclue Tablets in Patients With Acute or Chronic Gastritis
Led by Daewoong Pharmaceutical Co. LTD. · Updated on 2025-07-17
12000
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Fexuclue tablets on gastrointestinal symptoms in adults with acute or chronic gastritis. This observational study focuses on patient-reported outcomes before and after treatment to understand symptom improvements and medication convenience in a real-world setting. The study is sponsored by Daewoong Pharmaceutical Co. LTD. and collects data using an electronic patient-reported outcome (e-PRO) application. Participants will complete surveys on their subjective symptoms twice—once before and once after taking Fexuclue tablets. Additionally, a survey on medication convenience is completed at two weeks, with a possible extension up to four weeks after starting treatment. Both patients and investigators assess overall improvement using specific rating scales during this period. During the study, participants will self-report their symptoms and medication experience through the e-PRO application. Investigators will also evaluate symptom improvement based on clinical judgment. The main outcome is the proportion of patients who report symptom improvement within two to four weeks. Secondary measures include changes in symptom frequency and severity, symptom disappearance rates, and satisfaction with medication convenience. The total study participation lasts up to four weeks after treatment begins.
CONDITIONS
Brief Title
Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects between 19 and 75 years old at the time of consent
- Scheduled to receive Fexuclue tablets (fexuprazan) as approved
- Have at least one subjective symptom requiring medical treatment
- Able to understand information, voluntarily decide to participate, and provide written informed consent
You will not qualify if you...
- Have any contraindications for Fexuclue tablets as specified in approved labeling
- Deemed inappropriate for participation by the investigator for any reason not otherwise specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm eligibility and consent
Duration - Up to 4 weeks
Participants use an electronic application to report subjective symptoms before and after taking Fexuclue tablets. They also self-assess overall improvement and satisfaction with medication convenience at 2 to 4 weeks post-administration.
2 assessments via electronic application (before administration and at 2 to 4 weeks after administration)
Trial Site Locations
Total: 1 location
1
Masong Kim Internal Medicine Clinic
Seoul, South Korea
Actively Recruiting
Research Team
S
So Heui Kim
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here