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

Active, not recruiting

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Fexuprazan

• Registration Number: NCT05614752
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

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 Timeline

• Study Start: 2022-07-06
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Primary Completion: 2023-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8500

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 agreed to participate in this observation study and signed Informed Consent Form

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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

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

3. 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment group	Fexuprazan	treated with Fexuclue Tablet 40mg

Primary Outcome Measures

Name	Time	Method
Average score change in RDQ	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 Outcome Measures

Name	Time	Method
Overall improvement evaluated by the subjects	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
RDQ validity rate	At least 2 weeks (up to 8 weeks)	RDQ validity rate at least 2 weeks(up to 8 weeks) from baseline
changes in average score of the individual symptoms (reflux, heartburn, indigestion)	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)
Overall improvement evaluated by the researchers	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

Trial Locations

Locations (1)

Jeonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of