Gastroesophageal Reflux DiseaseNCT05660122
A Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab
An observational study of Gastroesophageal Reflux Disease, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab. 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
- 2,852 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2022to 11 Aug 2025
- 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
- Adult, Older adult
Study population: This observation research plan assumes the following. 1. level of signification, α=0.05 2. Distance from Mean to Limits = 0.067 3. Standard deviation of the amount of change at the time of two weeks compared to the baseline of the RDQ score = 1.66 As a result of calculating using PASS2020 based on the above assumptions, the number of study subjects required to conduct this study was 2,359. In consideration of the dropout rate of about 20% in the calculated results, we intend to recruit 3,000 study subjects.
Who may be able to join
- Adult men and women aged 19 to 75 years of age at the time of registration.
- A patient with erosive gastroesophageal reflux disease who is scheduled to administer Fexuclue Tab. for the first time based on the medical judgement of the researcher based on the medication authorization.
- A person who voluntarily agrees to participate in this observation study and signed the 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 participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;
- 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 Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab. in Patients With Erosive Gastroesophageal Reflux Disease
This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.
Read the detailed description
This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.
Subjects who met the inclusion/exclusion criteria will administer Fexuclue Tablet once a day for four weeks after registration, regardless of their meals. If esophagitis is not treated or symptoms continue after 4 weeks of administration, the subject will continue to administer Fexuclue Tablet for 4 more weeks (maximum administration period: 8 weeks).
- 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
Fexuclue Tablet 40mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | patients with gastroesophageal reflux disease Receives: Drug: Fexuprazan Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average score change in RDQ
Average score change in RDQ at 4 weeks (up to 8 weeks) from baseline
Measured: at 4 weeks (up to 8 weeks)
Secondary outcomes (4)
Average individual score change in RDQ
Average individual score change in RDQ at 4 weeks (up to 8 weeks) from baseline
Measured: at 4 weeks (up to 8 weeks)
RDQ validity rate
RDQ validity rate at 4 weeks (up to 8 weeks) from baseline
Measured: at 4 weeks (up to 8 weeks)
Overall improvement evaluated by the subjects
Overall improvement evaluated by the subjects at 4 weeks (up to 8 weeks) from baseline
Measured: at 4 weeks (up to 8 weeks)
Overall improvement evaluated by the researchers
Overall improvement evaluated by the researchers at 4 weeks (up to 8 weeks) from baseline
Measured: at 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 posted21 Dec 2022
- Study start11 Nov 2022
- Primary completion26 Dec 2024
- Study completion11 Aug 2025
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,852 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660122
- Sponsor's protocol ID
- DWFE_P405
- Status last verified
- Aug 2025
- First submitted
- 13 Dec 2022
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05660122
- Acronym / sponsor ID
- DWFE_P405
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,852 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 21 Dec 2022 (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 observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.
Detailed description
This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.
Subjects who met the inclusion/exclusion criteria will administer Fexuclue Tablet once a day for four weeks after registration, regardless of their meals. If esophagitis is not treated or symptoms continue after 4 weeks of administration, the subject will continue to administer Fexuclue Tablet for 4 more weeks (maximum administration period: 8 weeks).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: Fexuprazan Hydrochloridepatients with gastroesophageal reflux disease |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This observation research plan assumes the following. 1. level of signification, α=0.05 2. Distance from Mean to Limits = 0.067 3. Standard deviation of the amount of change at the time of two weeks compared to the baseline of the RDQ score = 1.66 As a result of calculating using PASS2020 based on the above assumptions, the number of study subjects required to conduct this study was 2,359. In consideration of the dropout rate of about 20% in the calculated results, we intend to recruit 3,000 study subjects.
Key inclusion criteria (3 listed)
- Adult men and women aged 19 to 75 years of age at the time of registration.
- A patient with erosive gastroesophageal reflux disease who is scheduled to administer Fexuclue Tab. for the first time based on the medical judgement of the researcher based on the medication authorization.
- A person who voluntarily agrees to participate in this observation study and signed the 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 participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;
- 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 TabletFexuclue Tablet 40mg | Drug | Treatment group |
Primary outcome
Average score change in RDQ
Time frame: at 4 weeks (up to 8 weeks)
Average score change in RDQ at 4 weeks (up to 8 weeks) from baseline
4 secondary outcomes
Average individual score change in RDQ
Time frame: at 4 weeks (up to 8 weeks)
RDQ validity rate
Time frame: at 4 weeks (up to 8 weeks)
Overall improvement evaluated by the subjects
Time frame: at 4 weeks (up to 8 weeks)
Overall improvement evaluated by the researchers
Time frame: at 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 4 Sep 2025.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 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 4 Sep 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?
Average score change in RDQ (time frame: at 4 weeks (up to 8 weeks)). 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 4 Sep 2025.