A Study to Evaluate the Efficacy and Safety of CnU Cap. 500 mg in Patients With Biliary Dyspepsia (NCT07016269) | Clinical Trial Compass
RecruitingPhase 4
A Study to Evaluate the Efficacy and Safety of CnU Cap. 500 mg in Patients With Biliary Dyspepsia
South Korea358 participantsStarted 2025-08-29
Plain-language summary
The objective of this clinical trial is to evaluate the efficacy and safety of CnU capsule 500 mg administration in patients with biliary dyspepsia
Who can participate
Age range
19 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
. Individuals who have voluntarily agreed to participate in this clinical trial
. Adults aged 19 years and older
. Individuals with pain localized to the epigastrium and/or right upper quadrant, as defined by the ROME IV diagnostic criteria
Exclusion criteria
. Patients with frequent biliary colic or biliary tract infections (e.g., severe pancreatic changes such as ileal resection, surgery, or partial ileitis, which may alter the composition of enterohepatic bile acid circulation).
. Patients with obstructive jaundice.
. Patients with liver disease.
. Patients with severe renal disease.
. Patients with severe biliary obstruction (due to the potential choleretic effect, symptoms may worsen).
. Patients with underlying conditions that may worsen biliary obstruction (e.g., cholangiocarcinoma, cholangitis, biliary cysts).
. Patients with acute cholecystitis.
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
Symptom improvement rate at Week 24 using the Global Overall Symptom Scale (GOS) in patients with biliary dyspepsia
. Patients with a clear etiology of dyspepsia (e.g., those with endoscopically or clinically confirmed GI abnormalities such as gastric ulcer, gastroparesis; regular NSAID users; or those with prominent heartburn).