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Completed

NCT Number: NCT05660122

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

This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.

Subjects who met the inclusion/exclusion criteria will administer Fexuclue Tablet once a day for four weeks after registration, regardless of their meals. If esophagitis is not treated or symptoms continue after 4 weeks of administration, the subject will continue to administer Fexuclue Tablet for 4 more weeks (maximum administration period: 8 weeks).

Who can participate

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

Inclusion criteria

  • Adult men and women aged 19 to 75 years of age at the time of registration.
  • A patient with erosive gastroesophageal reflux disease who is scheduled to administer Fexuclue Tab. for the first time based on the medical judgement of the researcher based on the medication authorization.
  • A person who voluntarily agrees to participate in this observation study and signed the 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 Hydrochloride

Drug

Fexuclue Tablet 40mg

Other names: Fexuclue Tablet

Primary outcomes

  1. Average score change in RDQ

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

    Average score change in RDQ at 4 weeks (up to 8 weeks) from baseline

Secondary outcomes

  1. Average individual score change in RDQ

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

    Average individual score change in RDQ at 4 weeks (up to 8 weeks) from baseline

  2. RDQ validity rate

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

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

  3. Overall improvement evaluated by the subjects

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

    Overall improvement evaluated by the subjects at 4 weeks (up to 8 weeks) from baseline

  4. Overall improvement evaluated by the researchers

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

    Overall improvement evaluated by the researchers 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 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
2024
Study completion
2025
First posted
Dec 21, 2022
Registry last updated
Sep 4, 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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