Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05886933
• Other study ID #: DWFE_P407
• Status: Active, not recruiting
• Start date: May 22, 2023
• 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: 10000
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• 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 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

2. A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.

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 Hydrochloride
Patient treated with Fexuprazan Hydrochloride (Fexuclue Tablet)

Locations

Country	Name	City	State
Korea, Republic of	Co&Ping Otolaryngology Clinic	Busan

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	Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)	Average score change in Reflux Disease Questionnaire (0 ~5) from baseline	at least 4 weeks (up to 8 weeks)
Primary	Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)	Average score change in Reflux Disease Questionnaire (0 ~5) from baseline	at least 4 weeks (up to 8 weeks)
Secondary	Changes in average score of the degree by symptoms (reflux, heartburn, indigestion)	Average score change in Reflux Disease Questionnaire (0 ~5) from baseline	at least 4 weeks (up to 8 weeks)
Secondary	Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion)	Average score change in Reflux Disease Questionnaire (0 ~5) from baseline	at least 4 weeks (up to 8 weeks)
Secondary	RDQ validity rate	RDQ validity rate at 4 weeks(up to 8 weeks) from baseline	at least 4 weeks (up to 8 weeks)
Secondary	RDQ loss rate	RDQ loss rate at 4 weeks(up to 8 weeks) from baseline	at least 4 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 4 weeks(up to 8 weeks) from baseline	at least 4 weeks (up to 8 weeks)
Secondary	Overall improvement evaluated by the researchers	Overall improvement result (scale 1~5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the researchers at 4 weeks(up to 8 weeks) from baseline	at least 4 weeks (up to 8 weeks)
Secondary	Quality of Life (GERD-HRQL) Total score change	Quality of Life (GERD-HRQL) Total score change at 4 weeks(up to 8 weeks) from baseline	at least 4 weeks (up to 8 weeks)