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Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05886933
Collaborator
(none)
18,000
Enrollment
1
Location
13.3
Anticipated Duration (Months)
1352.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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

Detailed Description

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
18000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
May 22, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Outcome Measures

Primary Outcome Measures

  1. Average score change [at 0 weeks (up to 3 days)]

    Average score change in Reflux Disease Questionnaire

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

    Average score change in Reflux Disease Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Adult aged 19 years to 75 years (on registration date)

  2. Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.

  3. Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.

  4. Patient who agreed to participate in this observation study and signed 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 has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.

  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 Co&Ping Otolaryngology Clinic Busan Korea, Republic of

Sponsors and Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Investigators

  • Principal Investigator: Homin Lee, Co&Ping Otolaryngology Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT05886933
Other Study ID Numbers:
  • DWFE_P407
First Posted:
Jun 2, 2023
Last Update Posted:
Jun 2, 2023
Last Verified:
May 1, 2023
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
Fexuprazan

Study Results

No Results Posted as of Jun 2, 2023