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A Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05660122
Collaborator
(none)
3,000
Enrollment
1
Location
15
Anticipated Duration (Months)
200.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fexuprazan Hydrochloride

Detailed 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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Treatment group

patients with gastroesophageal reflux disease

Drug: Fexuprazan Hydrochloride
Fexuclue Tablet 40mg
Other Names:
  • Fexuclue Tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Average score change [at 4 weeks (up to 8 weeks)]

      in Reflux Disease Questionnaire

    Secondary Outcome Measures

    1. Average score change [at 4 weeks (up to 8 weeks)]

      individual score in Reflux Disease Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 75 Years
    Sexes Eligible for Study:
    All
    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 to administer Fexuclue Tab. for the first time based on the medical judgement of the researcher based on the medication authorization.

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

    Exclusion Criteria:
    1. 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

    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 (the doctor in charge) is not suitable for participation in this observation study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kosin University Gospel Hospital Busan Korea, Republic of

    Sponsors and Collaborators

    • Daewoong Pharmaceutical Co. LTD.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewoong Pharmaceutical Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT05660122
    Other Study ID Numbers:
    • DWFE_P405
    First Posted:
    Dec 21, 2022
    Last Update Posted:
    Dec 21, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastroesophageal Reflux

    Study Results

    No Results Posted as of Dec 21, 2022