Clinical trial NCT07016269: A Study to Evaluate the Efficacy and Safety of CnU Cap. 500 mg in Patients With Biliary Dyspepsia
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Biliary Dyspepsia
Lead sponsor: Myungmoon Pharma. Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 358
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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.

Primary outcomes:
measure: Symptom improvement rate at Week 24 using the Global Overall Symptom Scale (GOS) in patients with biliary dyspepsia
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: 1. Symptom improvement rate using the GOS in patients with biliary dyspepsia 2. Change in dyspepsia symptom scores using the NDI-K 3. Change in quality of life scores using the NDI-K
timeFrame: Baseline, Week 4, Week 12, and Week 24
Other outcomes:
Locations:
Study officials:
References: