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

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

Completed

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ilsan Paik Hospital

Ilsan, Kyung-gi-do, 411-706, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ursodeoxycholic acid, thiamine, riboflavin

Drug

Primary outcomes

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

Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 14, 2015
Registry last updated: Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed