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Clinical Trials in South Korea / NCT07558707
Starting soon Observational

Fexuclue for Prevention of NSAIDs-Induced Peptic Ulcer in Real-World Practice

NCT07558707 · tracked via the Priya Life Science South Korea tracker
Sponsor
Daewoong Pharmaceutical Co. LTD
Phase
Observational
Started
2026-04-30
Last updated
2026-04-30

Condition(s) studied

Peptic UlcerNSAID-Induced Peptic Ulcer

Study summary

This study is a prospective, multi-center, observational study to evaluate the efficacy and safety of Fexuclue Tablet 20 mg in patients requiring prevention of NSAIDs-induced peptic ulcer in real-world clinical practice in Korea.

Patients receiving NSAIDs and requiring gastroprotective therapy will be enrolled and followed prospectively. The study will assess patient-reported outcomes (PROs) related to gastrointestinal symptoms, as well as safety outcomes.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults aged ≥19 years * Patients requiring NSAIDs therapy * Patients requiring prevention of NSAIDs-induced peptic ulcer * Patients prescribed Fexuclue Tablet 20 mg * Patients who provide written informed consent Exclusion Criteria: * Hypersensitivity to Fexuclue or its components * Severe hepatic impairment * Pregnant or breastfeeding women * Patients considered inappropriate by investigator

Primary outcome measure(s)

  • Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2 — Week 2
    Peptic ulcer symptoms will be assessed using a study-specific patient-reported outcome (PRO) questionnaire consisting of 6 symptom items. Each symptom is scored on a scale from 0 (none) to 4 (very severe). Symptom occurrence is defined as: Increase of ≥1 point in at least one symptom item compared to baseline Includes: New occurrence in asymptomatic patients Worsening in symptomatic patients The proportion (%) of patients with symptom occurrence at Week 2 will be calculated.

Trial sites (1)

FacilityCityRegionStatus
Multiple centers in Republic of Korea Seoul South Korea

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Other trials for the same condition

Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer Recruiting
Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07558707 on ClinicalTrials.gov ↗ ← All trials in South Korea