Gastroesophageal Reflux DiseaseNCT05886933
Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet
An observational study of Gastroesophageal Reflux Disease, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Fexuprazan Hydrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 9,846 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 May 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Referring to the minimum number of subjects required and the number of patients with gastroesophageal reflux disease in Korea, We expected to recruit about 16,000 people which is 0.2 %. However, since this study is conducted under daily medical care, we expected 10% to be dropout rate. Therefore the total study population is about 18,000
Who may be able to join
- Adult aged 19 years to 75 years (on registration date)
- Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.
- Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
- Patient who agreed to participate in this observation study and signed Informed Consent Form
Who cannot join
- 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
- A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Fexuprazan Hydrochloride
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexuprazan HydrochlorideDrug
Also called Fexuclue Tablet
Patient treated with Fexuprazan Hydrochloride (Fexuclue Tablet)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at least 4 weeks (up to 8 weeks)
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
Measured: at least 4 weeks (up to 8 weeks)
Secondary outcomes (7)
Changes in average score of the degree by symptoms (reflux, heartburn, indigestion)
Average score change in Reflux Disease Questionnaire (0 ~5) from baseline
Measured: at least 4 weeks (up to 8 weeks)
Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion)
Average score change in Reflux Disease Questionnaire (0 ~5) from baseline
Measured: at least 4 weeks (up to 8 weeks)
RDQ validity rate
RDQ validity rate at 4 weeks(up to 8 weeks) from baseline
Measured: at least 4 weeks (up to 8 weeks)
RDQ loss rate
RDQ loss rate at 4 weeks(up to 8 weeks) from baseline
Measured: at least 4 weeks (up to 8 weeks)
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
Measured: at least 4 weeks (up to 8 weeks)
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
Measured: at least 4 weeks (up to 8 weeks)
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
Measured: at least 4 weeks (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start22 May 2023
- Primary completion30 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 9,846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Homin Lee, Principal investigator, Co&Ping Otolaryngology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886933
- Sponsor's protocol ID
- DWFE_P407
- Status last verified
- Jan 2025
- First submitted
- 24 May 2023
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this point
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05886933
- Acronym / sponsor ID
- DWFE_P407
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,846 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Referring to the minimum number of subjects required and the number of patients with gastroesophageal reflux disease in Korea, We expected to recruit about 16,000 people which is 0.2 %. However, since this study is conducted under daily medical care, we expected 10% to be dropout rate. Therefore the total study population is about 18,000
Key inclusion criteria (4 listed)
- Adult aged 19 years to 75 years (on registration date)
- Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.
- Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
- Patient who agreed to participate in this observation study and signed Informed Consent Form
Key exclusion criteria (7 listed)
- A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet
- A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fexuprazan HydrochlorideAlso: Fexuclue TabletPatient treated with Fexuprazan Hydrochloride (Fexuclue Tablet) | Drug | – |
Primary outcome
Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)
Time frame: at least 4 weeks (up to 8 weeks)
Average score change in Reflux Disease Questionnaire (0 ~5) from baseline
Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)
Time frame: at least 4 weeks (up to 8 weeks)
Average score change in Reflux Disease Questionnaire (0 ~5) from baseline
7 secondary outcomes
Changes in average score of the degree by symptoms (reflux, heartburn, indigestion)
Time frame: at least 4 weeks (up to 8 weeks)
Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion)
Time frame: at least 4 weeks (up to 8 weeks)
RDQ validity rate
Time frame: at least 4 weeks (up to 8 weeks)
RDQ loss rate
Time frame: at least 4 weeks (up to 8 weeks)
Overall improvement evaluated by the subjects
Time frame: at least 4 weeks (up to 8 weeks)
Overall improvement evaluated by the researchers
Time frame: at least 4 weeks (up to 8 weeks)
Quality of Life (GERD-HRQL) Total score change
Time frame: at least 4 weeks (up to 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Undecided. Undecided at this point
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Homin Lee principal investigator
Co&Ping Otolaryngology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ) (time frame: at least 4 weeks (up to 8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.