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ID06948487

Observational Study on the Safety and Effectiveness of Fexuclue Tablets for Adults 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

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 twiceonce 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

Research Team

S

So Heui Kim

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