Unknown statusInterventionalPhase 4Updated May 9, 2023
Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction | NCT02415777 | Trialant
CompletedInterventionalPhase 4Updated Jan 22, 2016
Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction
ClinicalTrials.gov ID
NCT02415777
Lead Sponsor
Daewoong Pharmaceutical Co. LTD.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
168Actual
Last Update Posted
Jan 22, 2016Estimated
Start Date
Oct 2014
Primary Completion Date
Jul 2015Actual
Completion Date
Jul 2015Actual
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
Fatigue
Ursodeoxycholic acid, thiamine, riboflavin
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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