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

Phase 4

Completed

• Conditions: Fatigue
• Interventions: Drug: Ursodeoxycholic acid, thiamine, riboflavin

• Registration Number: NCT02415777
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-14
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• CIS greater than or equal to 76, HADS less than or equal to 10
• ALT greater than upper limit of normal OR fatty liver on US

Exclusion Criteria

• Subjects who have diseases that can cause fatigue
• Subjects who are taking medication that can cause fatigue

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
udca003	Ursodeoxycholic acid, thiamine, riboflavin	udca003
placebo	Ursodeoxycholic acid, thiamine, riboflavin	placebo of udca003

Primary Outcome Measures

Name	Time	Method
Rate of subjects whose CIS score has improved under 76 at week 8	8 weeks

Trial Locations

Locations (1)

Ilsan Paik Hospital; 🇰🇷 Ilsan, Kyung-gi-do, Korea, Republic of