NCT02415777

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

October 8, 2014

Last Update Submit

January 21, 2016

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Study Arms (2)

udca003

EXPERIMENTAL

udca003

Drug: Ursodeoxycholic acid, thiamine, riboflavin

placebo

PLACEBO COMPARATOR

placebo of udca003

Drug: Ursodeoxycholic acid, thiamine, riboflavin

Interventions

Ursodeoxycholic acid, thiamine, riboflavinDRUG
placeboudca003

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects who have diseases that can cause fatigue
  • Subjects who are taking medication that can cause fatigue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilsan Paik Hospital

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

Location

Related Publications (1)

  • 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.

    PMID: 26997458DERIVED

MeSH Terms

Conditions

Fatigue

Interventions

Ursodeoxycholic AcidThiamineRiboflavin

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesFlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2014

First Posted

April 14, 2015

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

KR(1)