Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction
NCT ID: NCT02415777
Last Updated: 2016-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
168 participants
INTERVENTIONAL
2014-10-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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udca003
udca003
Ursodeoxycholic acid, thiamine, riboflavin
placebo
placebo of udca003
Ursodeoxycholic acid, thiamine, riboflavin
Interventions
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Ursodeoxycholic acid, thiamine, riboflavin
Eligibility Criteria
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Inclusion Criteria
* ALT greater than upper limit of normal OR fatty liver on US
Exclusion Criteria
* Subjects who are taking medication that can cause fatigue
19 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
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Locations
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Ilsan Paik Hospital
Ilsan, Kyung-gi-do, South Korea
Countries
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References
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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.
Other Identifiers
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DW_UDCA003
Identifier Type: -
Identifier Source: org_study_id
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