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

27 april 2026 bijgewerkt door: Daewoong Pharmaceutical Co. LTD.

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

7000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Fexuclue Treatment Group
Patients requiring prevention of NSAIDs-induced peptic ulcer who are prescribed Fexuclue Tablet 20 mg in routine clinical practice.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2
Tijdsspanne: 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.
Week 2

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4
Tijdsspanne: 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
Week 4
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 8
Tijdsspanne: 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
Week 8
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 12
Tijdsspanne: 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
Week 12
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 2
Tijdsspanne: 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.
Week 2
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 4
Tijdsspanne: 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.
Week 4
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 8
Tijdsspanne: 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.
Week 8
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 12
Tijdsspanne: 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.
Week 12

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 april 2026

Primaire voltooiing (Geschat)

30 april 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

31 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2026

Eerst geplaatst (Werkelijk)

30 april 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 april 2026

Laatste update ingediend die voldeed aan QC-criteria

27 april 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DW_FEX_DB_04

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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