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

NCT02415777 Phase 4 COMPLETED

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

Details

Lead sponsor	Daewoong Pharmaceutical Co. LTD.
Phase	Phase 4
Status	COMPLETED
Enrolment	168
Start date	2014-10
Completion	2015-07

Conditions

• Fatigue

Interventions

• Ursodeoxycholic acid, thiamine, riboflavin

Primary outcomes

• Rate of subjects whose CIS score has improved under 76 at week 8 — 8 weeks

Countries

South Korea