Actively Recruiting
A Study to Evaluate the Efficacy and Safety of CnU Cap. 500 mg in Patients With Biliary Dyspepsia
Led by Myungmoon Pharma. Co. Ltd. · Updated on 2025-10-02
358
Participants Needed
6
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this clinical trial is to evaluate the efficacy and safety of CnU capsule 500 mg administration in patients with biliary dyspepsia
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of CnU Cap. 500 mg in Patients With Biliary Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, including pain lasting 30 minutes or longer, occurring at intervals, severe enough to interrupt daily activities or lead to emergency visits, not significantly related to bowel movements or relieved by posture or acid suppression
- Pain may be associated with nausea, vomiting, radiation to the back or right infrasubscapular region, or waking from sleep
- Individuals without any organic lesions on abdominal ultrasonography that could explain biliary colic symptoms due to gallstones
You will not qualify if you...
- Patients with frequent biliary colic or biliary tract infections
- Patients with obstructive jaundice
- Patients with liver disease
- Patients with severe renal disease
- Patients with severe biliary obstruction
- Patients with conditions that may worsen biliary obstruction such as cholangiocarcinoma, cholangitis, or biliary cysts
- Patients with acute cholecystitis
- Patients with clear causes of dyspepsia like gastric ulcer, gastroparesis, regular NSAID use, or prominent heartburn
- Patients with peptic ulcer disease
- 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 before screening
- Patients with a history of gastrointestinal surgery
- Patients hypersensitive to any components of the investigational product
- Patients with significant cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system disorders, or psychiatric illness affecting study participation
- Individuals with a history of drug or alcohol abuse
- Individuals with body mass index (BMI) of 35 kg/m² or higher
- Individuals with abnormal liver enzymes or bilirubin exceeding twice the upper normal limit
- Individuals with estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m²
- Individuals testing positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis
- Subjects taking prohibited medications within specified washout periods or alpha-methyldopa at any time
- Pregnant or lactating women
- Subjects or partners not using medically acceptable contraception during the study
- Individuals deemed unsuitable by the investigator for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Pusan National University Hospital
Busan, South Korea
Actively Recruiting
2
CHA Bundang Medical Center
Gyeonggi-do, South Korea
Actively Recruiting
3
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, South Korea
Actively Recruiting
4
Soonchunhyang University Cheonan Hospital
Gyeonggi-do, South Korea
Actively Recruiting
5
Inha University Hospital
Incheon, South Korea
Actively Recruiting
6
Gangnam Severance Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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