A Study to Evaluate the Efficacy and Safety of CnU Cap. 500 mg in Patients With Biliary Dyspepsia

Launched by MYUNGMOON PHARMA. CO. LTD. · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to test how effective and safe a new medication called CnU, taken as a 500 mg capsule, is for people suffering from biliary dyspepsia, which is a type of stomach pain related to the biliary system. The trial will involve multiple healthcare centers and will follow a process where some participants receive the actual medication while others receive a placebo (a pill that looks like the medication but has no active ingredients). The goal is to find out if CnU can help relieve symptoms and improve the quality of life for those affected by this condition.

To be eligible for the trial, participants must be adults aged 19 and older who experience specific types of abdominal pain that fit certain medical criteria. They should not have any serious underlying health issues, such as liver disease or recent gastrointestinal surgery, that could complicate the study. Throughout the trial, participants can expect regular check-ups and monitoring to assess their response to the treatment. It's important to note that the trial is not yet recruiting participants, so it will begin at a later date.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Individuals who have voluntarily agreed to participate in this clinical trial
• • 2. Adults aged 19 years and older
• • 3. 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 to interrupt daily activities or lead to an emergency department visit
• • 4. Not significantly (\<20%) related to bowel movements
• • 5. Not significantly (\<20%) relieved by postural change or acid suppression
• * 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 ultrasonography performed during screening that could explain biliary colic symptoms due to gallstones
• Exclusion Criteria:
• • 1. Medical History
• • 1. 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).
• • 2. Patients with obstructive jaundice.
• • 3. Patients with liver disease.
• • 4. Patients with severe renal disease.
• • 5. Patients with severe biliary obstruction (due to the potential choleretic effect, symptoms may worsen).
• • 6. Patients with underlying conditions that may worsen biliary obstruction (e.g., cholangiocarcinoma, cholangitis, biliary cysts).
• • 7. Patients with acute cholecystitis.
• • 8. Patients with a clear etiology of dyspepsia (e.g., those with endoscopically or clinically confirmed GI abnormalities such as gastritis, gastric ulcer, gastroparesis; regular NSAID users; or those with prominent heartburn).
• • 9. Patients with peptic ulcer disease (due to the potential for mucosal irritation and symptom aggravation).
• • 10. Patients with inflammatory bowel diseases such as Crohn's disease.
• • 11. Patients with cholestasis.
• • 12. Patients with abnormal gallbladder contractility.
• • 13. Patients with a history of malignancy within 5 years prior to screening.
• • 14. Patients with a history of gastrointestinal surgery.
• • 15. Patients known to be hypersensitive to any components or excipients of the investigational product.
• • 16. 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 affect participation in the study.
• • 17. Individuals with a history of drug or alcohol abuse.
• • 2. Abnormal Laboratory Findings at Screening
• • 1. Body Mass Index (BMI) ≥ 35 kg/m².
• • 2. ALT or AST \> 2.0 × upper normal limit (UNL).
• • 3. Total bilirubin \> 2.0 × UNL.
• • 4. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m² (based on the CKD-EPI equation).
• 5. 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
• Subjects taking the following medications must undergo the specified washout period before enrollment:
• • 1. 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)
• • 2. Within 2 weeks prior to screening: Cholestyramine, colestipol, activated charcoal, or antacids containing magnesium or aluminum hydroxide
• • 3. 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
• • 4. 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
• Subjects or their partners who are not using medically acceptable methods of contraception throughout the study period will be excluded. Acceptable methods include:
• • 1. Proven intrauterine devices (IUD) or intrauterine systems (IUS)
• • 2. Dual barrier methods (e.g., male condom with diaphragm or cervical cap, used with a spermicide)
• • 3. Permanent sterilization (e.g., vasectomy, tubal ligation, salpingectomy, or hysterectomy) 6. Other Individuals deemed by the investigator to be unsuitable for participation in this clinical trial for any reason.