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

Last updated: January 21, 2025
Sponsor: Daewoong Pharmaceutical Co. LTD.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Treatment

Fexuprazan Hydrochloride

Clinical Study ID

NCT05660122
DWFE_P405
  • Ages 19-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult men and women aged 19 to 75 years of age at the time of registration.

  2. A patient with erosive gastroesophageal reflux disease who is scheduled toadminister Fexuclue Tab. for the first time based on the medical judgement of theresearcher based on the medication authorization.

  3. A person who voluntarily agrees to participate in this observation study and signedthe informed consent form.

Exclusion

Exclusion Criteria:

  1. A person who falls under the prohibition of administration according to thepermission for Fexuclue Tablet

  • Patients with hypersensitivity to the components of Fexuclue tablet or Fexucluetablet and a history thereof

  • Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containingpreparations

  • Pregnant and lactating women

  • Patients with genetic problems such as galactose intolerance, Lapp lactasedeficiency, or glucose-galactose malabortion

  1. A person who participates in another clinical trial and is administering (applying)clinical trial drugs or clinical trial medical devices;

  2. In addition to the above, a person who has determined that the researcher (thedoctor in charge) is not suitable for participation in this observation study

Study Design

Total Participants: 2874
Treatment Group(s): 1
Primary Treatment: Fexuprazan Hydrochloride
Phase:
Study Start date:
November 11, 2022
Estimated Completion Date:
July 31, 2025

Study Description

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).

Connect with a study center

  • Kosin University Gospel Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

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