NSAID-Induced Peptic Ulcer, Peptic Ulcer
Conditions
Keywords
NSAIDs, Fexuprazan, PRO, Real-World, Peptic Ulcer Prevention
Brief 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.
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.
Interventions
None listed
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4 | Week 4 | Peptic ulcer symptom occurrence is defined using the same criteria as the primary endpoint (≥1-point increase in at least one symptom item from baseline). The proportion (%) of patients with symptom occurrence will be calculated at Week 4 |
| Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 8 | Week 8 | Peptic ulcer symptom occurrence is defined using the same criteria as the primary endpoint (≥1-point increase in at least one symptom item from baseline). The proportion (%) of patients with symptom occurrence will be calculated at Week 8 |
| Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 12 | Week 12 | Peptic ulcer symptom occurrence is defined using the same criteria as the primary endpoint (≥1-point increase in at least one symptom item from baseline). The proportion (%) of patients with symptom occurrence will be calculated at Week 12 |
| Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 2 | Week 2 | Gastrointestinal symptoms will be assessed using a study-specific PRO questionnaire with 6 symptom items, each scored from 0 (none) to 4 (very severe). The total score ranges from 0 to 24, with higher scores indicating more severe symptoms. The outcome measure is defined as the change from baseline in total score at each time point. |
| Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 4 | Week 4 | Gastrointestinal symptoms will be assessed using a study-specific PRO questionnaire with 6 symptom items, each scored from 0 (none) to 4 (very severe). The total score ranges from 0 to 24, with higher scores indicating more severe symptoms. The outcome measure is defined as the change from baseline in total score at each time point. |
| Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 8 | Week 8 | Gastrointestinal symptoms will be assessed using a study-specific PRO questionnaire with 6 symptom items, each scored from 0 (none) to 4 (very severe). The total score ranges from 0 to 24, with higher scores indicating more severe symptoms. The outcome measure is defined as the change from baseline in total score at each time point. |
| Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 12 | Week 12 | Gastrointestinal symptoms will be assessed using a study-specific PRO questionnaire with 6 symptom items, each scored from 0 (none) to 4 (very severe). The total score ranges from 0 to 24, with higher scores indicating more severe symptoms. The outcome measure is defined as the change from baseline in total score at each time point. |
Countries
South Korea
Contacts
CONTACTSoHeui Kim
Outcome results
None listed