Fexuclue for Prevention of NSAIDs-Induced Peptic Ulcer in Real-World Practice
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
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: SoHeui Kim
- Numer telefonu: 82-10-2994-5887
- E-mail: 2210325@daewoong.co.kr
Lokalizacje studiów
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Seoul, Korea Południowa
- Multiple centers in Republic of Korea
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Kontakt:
- SoHeui Kim
- Numer telefonu: 82-10-2994-5887
- E-mail: 2210325@daewoong.co.kr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
This study will enroll adult patients aged 19 years or older who require prevention of NSAIDs-induced peptic ulcer in routine clinical practice in Korea. Eligible patients are those who are prescribed Fexuclue Tablet 20 mg based on the physician's clinical judgment.
Patients receiving NSAIDs and requiring gastroprotective therapy will be prospectively enrolled from multiple centers under real-world conditions. Treatment decisions will be made according to routine clinical practice.
Patients with contraindications to the study drug or those deemed inappropriate by the investigator will be excluded.
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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Fexuclue Treatment Group
Patients requiring prevention of NSAIDs-induced peptic ulcer who are prescribed Fexuclue Tablet 20 mg in routine clinical practice.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2
Ramy czasowe: Week 2
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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. |
Week 2
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4
Ramy czasowe: Week 4
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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 |
Week 4
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Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 8
Ramy czasowe: Week 8
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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 |
Week 8
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Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 12
Ramy czasowe: Week 12
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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 |
Week 12
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Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 2
Ramy czasowe: Week 2
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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. |
Week 2
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Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 4
Ramy czasowe: Week 4
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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. |
Week 4
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Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 8
Ramy czasowe: Week 8
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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. |
Week 8
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Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 12
Ramy czasowe: Week 12
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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. |
Week 12
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- DW_FEX_DB_04
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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