Fexuclue for Prevention of NSAIDs-Induced Peptic Ulcer in Real-World Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peptic Ulcer, NSAID-Induced Peptic Ulcer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy and Safety of Fexuclue Tablet 20 mg in Patients Requiring NSAIDs-Induced Peptic Ulcer Prevention
Overview
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.
Detailed description
This study is a prospective, multi-center, observational study conducted in Korea to evaluate the efficacy and safety of Fexuclue Tablet 20 mg in patients requiring prevention of NSAIDs-induced peptic ulcer in routine clinical practice.
Adult patients receiving NSAIDs who require prevention of peptic ulcer will be enrolled after providing written informed consent. Treatment with Fexuclue Tablet will be prescribed based on the physician's clinical judgment in accordance with approved labeling.
The study will primarily evaluate patient-reported outcomes (PROs) related to gastrointestinal symptoms using electronic PRO (ePRO) questionnaires. Assessments will be conducted at baseline and at approximately 2, 4, 8, and 12 weeks after treatment initiation.
Safety will be assessed by monitoring adverse events. This study aims to provide real-world evidence on symptom prevention and improvement in patients requiring NSAIDs-induced peptic ulcer prevention.
Primary outcome measures
- Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2 [Time frame: Week 2]
Secondary outcome measures (7)
- Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4 [Time frame: Week 4]
- Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 8 [Time frame: Week 8]
- Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 12 [Time frame: Week 12]
- Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 2 [Time frame: Week 2]
- Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 4 [Time frame: Week 4]
- Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 8 [Time frame: Week 8]
- Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 12 [Time frame: Week 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Multiple centers in Republic of Korea — Seoul
Identifiers
NCT: NCT07558707 · DW_FEX_DB_04