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NCT Number: NCT06948487

Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis

This study aims to evaluate the efficacy of Fexuclue tablets in improving gastrointestinal symptoms based on patient-reported outcomes (PROs), by comparing assessments before and after treatment.

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Key information

Conditions

Gastritis Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases Stomach Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Masong Kim Internal Medicine Clinic

Seoul, South Korea

Location status: Recruiting

Location contact

Jingun Kim

CONTACT

About this study

In this observational study, patient-reported data will be collected using an electronic application (e-PRO). The survey on subjective symptoms will be administered twice-once before and once after the administration of Fexuclue tablets. Additionally, a survey on medication convenience will be conducted once at 2 weeks (up to a maximum of 4 weeks) post-administration.

At the same time point (2 to 4 weeks after administration), patients will self-assess their overall improvement through the e-PRO application. Investigators will also evaluate final improvement based on clinical judgment in a real-world setting and record the outcome in the Case Report Form (CRF).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult subjects between the ages of 19 and 75 years at the time of obtaining written informed consent.
  • Subjects who are scheduled to receive Fexuclu tablets (fexuprazan) in accordance with the approved indication.
  • Subjects who present with at least one subjective symptom requiring medical treatment
  • Subjects who are capable of understanding the information provided, have voluntarily decided to participate in this observational study, and have provided written informed consent for the use of their personal data.

Exclusion criteria

  • Individuals who fall under any contraindications for the administration of Fexuclu tablets (fexuprazan) as specified in the approved labeling.
  • Individuals who are deemed by the investigator (attending physician) to be inappropriate for participation in this observational study for any reason not otherwise specified.

Treatment and study plan

Primary outcomes

  1. The proportion of subjects with improvement in subjective symptoms

    Time frame: 2 weeks(up to 4 weeks)

    The proportion of subjects with improvement in subjective symptoms at Week 2 (up to Week 4) compared to baseline.

Secondary outcomes

  1. Change from baseline in the mean frequency scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (daily)

    Time frame: 2 weeks(up to 4 weeks)

    Change from baseline in the mean frequency scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (daily) at 2 weeks(up to 4 weeks)

  2. Change from baseline in the mean severity scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (very severe)

    Time frame: 2 weeks(up to 4 weeks)

    Change from baseline in the mean severity scores of individual subjective symptoms assessed at each time point using a 5-point scale ranging from 0 (not at all) to 4 (very severe) at 2 weeks(up to 4 weeks)

  3. Disappearance rate of subjective symptoms

    Time frame: 2 weeks(up to 4 weeks)

    Disappearance rate of subjective symptoms at 2 weeks(up to 4 weeks)

  4. Overall improvement assessed at each time point by both the subject and the investigator using the Final Improvement Assessment, which consists of a 5-point scale ranging from 'fully recovered' to 'worsened'

    Time frame: 2 weeks(up to 4 weeks)

    Overall improvement assessed at each time point by both the subject and the investigator using the Final Improvement Assessment, which consists of a 5-point scale ranging from 'fully recovered' to 'worsened' at 2 weeks(up to 4 weeks)

  5. Patient-reported satisfaction with medication intake convenience assessed at Week 2 (up to Week 4) compared to baseline, using a 5-point scale ranging from 'very convenient' to 'very inconvenient'

    Time frame: 2 weeks(up to 4 weeks)

    Patient-reported satisfaction with medication intake convenience assessed at Week 2 (up to Week 4) compared to baseline, using a 5-point scale ranging from 'very convenient' to 'very inconvenient' at 2 weeks(up to 4 weeks)

Study contacts

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

So Heui 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 on the Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Apr 29, 2025
Registry last updated
Jul 17, 2025

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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