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Completed

NCT Number: NCT05614752

Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab

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

Jeonbuk National University Hospital

Jeonju, 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 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 participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;
  • 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

Drug

Fexuclue Tablet 40mg

Primary outcomes

  1. Average score change in RDQ

    Time frame: At least 2 weeks (up to 8 weeks)

    Average score change in RDQ at least 2 weeks (up to 8 weeks) compared to baseline

Secondary outcomes

  1. changes in average score of the individual symptoms (reflux, heartburn, indigestion)

    Time frame: At least 2 weeks (up to 8 weeks)

    changes in average score of the individual symptoms (reflux, heartburn, indigestion) at least 2 weeks(up to 8 weeks) from baseline (0~5)

  2. RDQ validity rate

    Time frame: At least 2 weeks (up to 8 weeks)

    RDQ validity rate at least 2 weeks(up to 8 weeks) from baseline

  3. Overall improvement evaluated by the subjects

    Time frame: At least 2 weeks (up to 8 weeks)

    Overall improvement result (scale 1~5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the subjects at least 2 weeks(up to 8 weeks) from baseline

  4. Overall improvement evaluated by the researchers

    Time frame: At least 2 weeks (up to 8 weeks)

    Overall improvement (scale 1~5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the researchers at least 2 weeks(up to 8 weeks) from baseline

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

A Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab. in Patients With Erosive Gastroesophageal Reflux Disease

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 14, 2022
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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