A Study to Evaluate the Efficacy and Safety of CnU Cap. 500 mg in Patients With Biliary Dy
The objective of this clinical trial is to evaluate the efficacy and safety of CnU capsule 500 mg administration in patients with biliary dyspepsia
| Condition(s) | Biliary Dyspepsia |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 |
| Who can participate | \[Inclusion Criteria\] 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 an |
| Ages | 19 Years |
| Sex | All |
| Lead sponsor | Myungmoon Pharma. Co. Ltd. |
| Locations | Busan, South Korea; Gyeonggi-do, South Korea; Gyeonggi-do, South Korea; Gyeonggi-do, South Korea; Incheon, South Korea; Seoul, South Korea |
| Start date | 2025-08-29 |
| NCT ID | NCT07016269 |
| Official listing | https://clinicaltrials.gov/study/NCT07016269 |