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NCT Number: NCT07558707

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

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.

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Key information

Conditions

Peptic Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases NSAID-Induced Peptic Ulcer Stomach Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2

    Time frame: 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 outcomes

  1. Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4

    Time frame: 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

  2. Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 8

    Time frame: 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

  3. Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 12

    Time frame: 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

  4. Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 2

    Time frame: 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.

  5. Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 4

    Time frame: 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.

  6. Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 8

    Time frame: 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.

  7. Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 12

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

SoHeui Kim

CONTACT

[email protected]

82-10-2994-5887

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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