CnU 500 mg for biliary dyspepsia

Multi-center, Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial for the Evauation of the Efficacy and Safety of CnU Cap. 500 mg in Patients With Biliary Dyspepsia

This trial will test whether taking CnU 500 mg capsules helps relieve pain and is safe for adults with biliary dyspepsia.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 358 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Myungmoon Pharma. Co. Ltd. (Industry-sponsored)
• Drugs / interventions: Radiation
• Locations: 6 sites (Busan and 5 other locations)
• Trial ID: NCT07016269 on ClinicalTrials.gov

What this trial studies

Adults who meet Rome IV criteria for functional gallbladder or sphincter-related biliary pain and who have no explanatory lesions on abdominal ultrasound will be enrolled at three South Korean hospitals. Participants will receive either CnU 500 mg (two 250 mg capsules) or a matching placebo and will be monitored for symptom changes and adverse events. The trial targets episodes of epigastric or right upper quadrant pain that last 30 minutes or more and significantly interrupt daily activities. Primary outcomes will compare symptom relief and tolerability between the CnU and placebo groups.

Who should consider this trial

Good fit: Adults aged 19 or older with epigastric and/or right upper quadrant pain meeting Rome IV criteria and no organic lesions on screening abdominal ultrasound are ideal candidates.

Not a fit: Patients with structural gallbladder or biliary disease on imaging, pain patterns that are daily or clearly related to bowel movements or relieved by posture or acid suppression, or those under 19 are unlikely to benefit from this trial.

Why it matters

Potential benefit: If effective, CnU could provide a convenient oral option to reduce pain and improve daily function for people with biliary dyspepsia.

How similar studies have performed: There is limited high-quality evidence for drug treatments specifically for functional biliary pain, so pharmacologic approaches like CnU remain relatively unproven.

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 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.

Where this trial is running

Busan and 5 other locations

• Pusan National University Hospital — Busan, South Korea (Recruiting)
• CHA Bundang Medical Center — Gyeonggi-do, South Korea (Recruiting)
• Hallym University Dongtan Sacred Heart Hospital — Gyeonggi-do, South Korea (Recruiting)
• Soonchunhyang University Cheonan Hospital — Gyeonggi-do, South Korea (Recruiting)
• Inha University Hospital — Incheon, South Korea (Recruiting)
• Gangnam Severance Hospital — Seoul, South Korea (Recruiting)

Conditions Biliary Dyspepsia