RecruitingPhase 4NCT07005752

A Study to Evaluate the Efficacy and Safety of CnU Capsule 750 mg in Patients With Cholesterol Gallstones(GB Stones).

Multi-center, Randomized, Double-blind, Active Controlled, Parallel Clinical Trial for the Evaluation of the Efficacy and Safety of CnU Cap. 750 mg in Patients With Cholesterol Gallstone


Sponsor

Myungmoon Pharma. Co. Ltd.

Enrollment

484 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this clinical trial is to evaluate the efficacy and safety of CnU capsule 750 mg administration in patients with Cholesterol gallstone (radiolucent gallstones)


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CnU cap. 250mg & Ursa placebo tab. 200mg and a drug called Ursa tab. 200mg & CnU placebo cap. 250mg for people with cholesterol cholelithiasis. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCnU cap. 250mg & Ursa placebo tab. 200mg

CnU capsule(Magnesium Salt Trihydrate of Chenodeoxycholic Acid and Ursodeoxycholic Acid) and Ursa placebo tablet will be orally administered three times a day after meals at regular intervals for a total of 24 weeks.

DRUGUrsa tab. 200mg & CnU placebo cap. 250mg

Ursa tablet(Ursodeoxycholic Acid) and CnU placebo capsule will be orally administered three times a day after meals at regular intervals for a total of 24 weeks.


Locations(13)

Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Pusan National University Hospital

Busan, South Korea

Kyungpook National University Hospital

Daegu, South Korea

CHA Bundang Medical Center

Gyeonggi-do, South Korea

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, South Korea

Soonchunhyang University Cheonan Hospital

Gyeonggi-do, South Korea

Inha University Hospital

Incheon, South Korea

Inje University Sanggye Paik Hospital

Seoul, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Eunpyeong St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07005752