NCT02415777
Completed
Phase 4
Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction
Daewoong Pharmaceutical Co. LTD.1 site in 1 country168 target enrollmentOctober 2014
ConditionsFatigue
InterventionsUrsodeoxycholic acid, thiamine, riboflavin
Overview
- Phase
- Phase 4
- Intervention
- Ursodeoxycholic acid, thiamine, riboflavin
- Conditions
- Fatigue
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Rate of subjects whose CIS score has improved under 76 at week 8
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
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
Arms & Interventions
udca003
udca003
Intervention: Ursodeoxycholic acid, thiamine, riboflavin
placebo
placebo of udca003
Intervention: Ursodeoxycholic acid, thiamine, riboflavin
Outcomes
Primary Outcomes
Rate of subjects whose CIS score has improved under 76 at week 8
Time Frame: 8 weeks
Study Sites (1)
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