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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: SoHeui Kim
- Número de teléfono: 82-10-2994-5887
- Correo electrónico: 2210325@daewoong.co.kr
Ubicaciones de estudio
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Seoul, Corea del Sur
- Multiple centers in Republic of Korea
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Contacto:
- SoHeui Kim
- Número de teléfono: 82-10-2994-5887
- Correo electrónico: 2210325@daewoong.co.kr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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.
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DW_FEX_DB_04
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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