Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction

Phase 4 Completed 168 enrolled Daewoong Pharmaceutical Co. LTD.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'URSA SOFT CAP. (UDCA-003)' in fatigue patients with liver dysfunction

Timeline

Start: 2014-10
Primary completion: 2015-07
Completion: 2015-07

Outcome

Met primary endpoint

paper The rate of CIS improvement at the end-point was 79.76% and 45.68% in the therapy and placebo groups, respectively (p < 0.05). PMID 26997458 ↗

Publications

Oh B, Choi WS, Park SB, Cho B, Yang YJ, Lee ES, Lee JH. Efficacy and safety of ursodeoxycholic acid composite on fatigued patients with elevated liver function and/or fatty liver: a multi-centre, randomised, double-blinded, placebo-controlled trial. Int J Clin Pract. 2016 Apr;70(4):302-11. doi: 10.1111/ijcp.12790. Epub 2016 Mar 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Riboflavin	Other / unclassified	—	—
Subject	Thiamine	Other / unclassified	—	—
Subject	Ursodeoxycholic Acid	Small molecule	—	—

Indications

No indication recorded.