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OpenTrials
Completed

NCT Number: NCT05886933

Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

This observational study is a large-scale, prospective, and multi-institutional observational study.

Patients from 19 to 75 years of age, will take a self-assessment (PRO) during the study period before and after administration of Pexuclue tablet.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Co&Ping Otolaryngology Clinic

Busan, South Korea

About this study

Data will be collected based on patient's medical records from daily visit. Enrolled subjects will take a Patient Reported Outcome (PRO) survey including Quality of life evaluation (GERD-HRQL) and self-awareness symptom (RDQ).

The survey will be done twice (before and after the administration of Fexuclue tablet) electronically through an application (e-PRO).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult aged 19 years to 75 years (on registration date)
  • Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.
  • Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
  • Patient who agreed to participate in this observation study and signed Informed Consent Form

Exclusion criteria

  • A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet
  • Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof
  • Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations
  • Pregnant and lactating women
  • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
  • A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
  • In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study

Treatment and study plan

Fexuprazan Hydrochloride

Drug

Patient treated with Fexuprazan Hydrochloride (Fexuclue Tablet)

Other names: Fexuclue Tablet

Primary outcomes

  1. Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)

    Time frame: at least 4 weeks (up to 8 weeks)

    Average score change in Reflux Disease Questionnaire (0 ~5) from baseline

  2. Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)

    Time frame: at least 4 weeks (up to 8 weeks)

    Average score change in Reflux Disease Questionnaire (0 ~5) from baseline

Secondary outcomes

  1. Changes in average score of the degree by symptoms (reflux, heartburn, indigestion)

    Time frame: at least 4 weeks (up to 8 weeks)

    Average score change in Reflux Disease Questionnaire (0 ~5) from baseline

  2. Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion)

    Time frame: at least 4 weeks (up to 8 weeks)

    Average score change in Reflux Disease Questionnaire (0 ~5) from baseline

  3. RDQ validity rate

    Time frame: at least 4 weeks (up to 8 weeks)

    RDQ validity rate at 4 weeks(up to 8 weeks) from baseline

  4. RDQ loss rate

    Time frame: at least 4 weeks (up to 8 weeks)

    RDQ loss rate at 4 weeks(up to 8 weeks) from baseline

  5. Overall improvement evaluated by the subjects

    Time frame: at least 4 weeks (up to 8 weeks)

    Overall improvement result (scale 1~5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the subjects at 4 weeks(up to 8 weeks) from baseline

  6. Overall improvement evaluated by the researchers

    Time frame: at least 4 weeks (up to 8 weeks)

    Overall improvement result (scale 1~5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the researchers at 4 weeks(up to 8 weeks) from baseline

  7. Quality of Life (GERD-HRQL) Total score change

    Time frame: at least 4 weeks (up to 8 weeks)

    Quality of Life (GERD-HRQL) Total score change at 4 weeks(up to 8 weeks) from baseline

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet in Patients With Erosive Gastroesophageal Reflux Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2023
Registry last updated
Jan 24, 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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