Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet (NCT05886933) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet
South Korea9,846 participantsStarted 2023-05-22
Plain-language 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.
Who can participate
Age range
19 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)
Timeframe: at least 4 weeks (up to 8 weeks)
2
Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)