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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05614752
• Other study ID #: DWFE_P406
• Status: Active, not recruiting
• Start date: July 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Fexuprazan
Fexuclue Tablet 40mg

Locations

Country	Name	City	State
Korea, Republic of	Jeonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average score change in RDQ	Average score change in RDQ at least 2 weeks (up to 8 weeks) compared to baseline	At least 2 weeks (up to 8 weeks)
Secondary	changes in average score of the individual symptoms (reflux, heartburn, indigestion)	changes in average score of the individual symptoms (reflux, heartburn, indigestion) at least 2 weeks(up to 8 weeks) from baseline (0~5)	At least 2 weeks (up to 8 weeks)
Secondary	RDQ validity rate	RDQ validity rate at least 2 weeks(up to 8 weeks) from baseline	At least 2 weeks (up to 8 weeks)
Secondary	Overall improvement evaluated by the subjects	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	At least 2 weeks (up to 8 weeks)
Secondary	Overall improvement evaluated by the researchers	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	At least 2 weeks (up to 8 weeks)