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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05886933
Other study ID # DWFE_P407
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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