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RECRUITING
NCT07005752
PHASE4

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

Sponsor: Myungmoon Pharma. Co. Ltd.

View on ClinicalTrials.gov

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)

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

484

Start Date

2025-07-28

Completion Date

2026-06

Last Updated

2025-10-02

Healthy Volunteers

No

Interventions

DRUG

CnU 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.

DRUG

Ursa 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 (6)

Pusan National University Hospital

Busan, 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

Gangnam Severance Hospital

Seoul, South Korea