Back to resultsClinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction
Primary Purpose
Fatigue
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ursodeoxycholic acid, thiamine, riboflavin
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue
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
Sites / Locations
- Ilsan Paik Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
udca003
placebo
Arm Description
udca003
placebo of udca003
Outcomes
Primary Outcome Measures
Rate of subjects whose CIS score has improved under 76 at week 8
Secondary Outcome Measures
Full Information
NCT ID
NCT02415777
First Posted
October 8, 2014
Last Updated
January 21, 2016
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT02415777
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
udca003
Arm Type
Experimental
Arm Description
udca003
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo of udca003
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid, thiamine, riboflavin
Primary Outcome Measure Information:
Title
Rate of subjects whose CIS score has improved under 76 at week 8
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
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
Facility Information:
Facility Name
Ilsan Paik Hospital
City
Ilsan
State/Province
Kyung-gi-do
ZIP/Postal Code
411-706
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26997458
Citation
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. Erratum In: Int J Clin Pract. 2017 Feb;71(2):
Results Reference
derived
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction
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