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Tests treatment safety and results for Biliary Dyspepsia
Official title A Study to Evaluate the Efficacy and Safety of CnU Cap. 500 mg in Patients With Biliary Dyspepsia
ClinicalTrials.gov ID: NCT07016269
What this study is testing
What is CnU capsule 500 mg(250mg 2 capsule)?
CnU capsule 500 mg(250mg 2 capsule) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for biliary dyspepsia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this clinical trial is to evaluate the efficacy and safety of CnU capsule 500 mg administration in patients with biliary dyspepsia
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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
- Rome IV criteria(Functional gallbladder and sphincter of Oddi disorders Diagnostic criteria) 1) Builds up to a steady level and lasts 30 minutes or...
- Supportive criteria: The pain may be associated with: 1) Nausea and vomiting 2) Radiation to the back and/or right infrasubscapular region 3) Waking...
You likely can't join if
- ] 1\. Medical History
- Patients with frequent biliary colic or biliary tract infections (e.g., severe pancreatic changes such as ileal resection, surgery, or partial...
- 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).
See the full eligibility 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
- Rome IV criteria(Functional gallbladder and sphincter of Oddi disorders Diagnostic criteria) 1) Builds up to a steady level and lasts 30 minutes or longer 2) Occurring at different intervals (not daily) 3) Severe enough...
- Supportive criteria: The pain may be associated with: 1) Nausea and vomiting 2) Radiation to the back and/or right infrasubscapular region 3) Waking from sleep 4\. Individuals without any organic lesions on abdominal...
- ] 1\. Medical History
- 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...
- 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.
- 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).
- Patients with peptic ulcer disease (due to the potential for mucosal irritation and symptom aggravation).
- Patients with inflammatory bowel diseases such as Crohn's disease.
- Patients with cholestasis.
- Patients with abnormal gallbladder contractility.
- Patients with a history of malignancy within 5 years prior to screening.
- Patients with a history of gastrointestinal surgery.
- Patients known to be hypersensitive to any components or excipients of the investigational product.
- Patients with clinically significant disorders of the cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous systems, or with a history or presence of psychiatric illness that may significantly...
- Individuals with a history of drug or alcohol abuse. 2\. Abnormal Laboratory Findings at Screening
- Body Mass Index (BMI) ≥ 35 kg/m².
- ALT or AST \> 2.0 × upper normal limit (UNL).
- Total bilirubin \> 2.0 × UNL.
- Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m² (based on the CKD-EPI equation).
- Positive serologic test results for any of the following: \- Hepatitis B surface antigen (HBsAg)
- Hepatitis C antibody (HCV Ab)
- Human immunodeficiency virus antibody (HIV Ab)
- Syphilis reagin test 3\. Prohibited Concomitant Medications and Therapies people taking the following medications must undergo the specified washout period before enrollment:
- Within 1 week prior to screening: Drugs that stimulate bile secretion (e.g., estrogens, hormonal contraceptives, certain lipid-lowering agents) Drugs that reduce blood cholesterol (e.g., clofibrate)
- Within 2 weeks prior to screening: Cholestyramine, colestipol, activated charcoal, or antacids containing magnesium or aluminum hydroxide
- Within 4 weeks prior to screening: Oral gallstone-dissolving agents such as chenodeoxycholic acid (CDCA), ursodeoxycholic acid (UDCA), HMG-CoA reductase inhibitors, or terpene-based drugs
- Within 4 weeks prior to screening: Bile acid therapies The following medication is strictly prohibited, regardless of washout period:
- Alpha-methyldopa 4\. Pregnant or lactating women will be excluded from the study. 5\. Contraception people or their partners who are not using medically acceptable methods of contraception throughout the study period...
The study team makes the final eligibility decision.
Where it's taking place
- Busan, South Korea
- Gyeonggi-do, South Korea
- Incheon, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Busan, South Korea; Gyeonggi-do, South Korea; Incheon, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.