NCT02418130
Completed
Phase 4
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of 'Ursa Complex Soft Cap. (UDCA-004)' in Patients With Physical Fatigue.
Daewoong Pharmaceutical Co. LTD.1 site in 1 country166 target enrollmentOctober 2014
ConditionsFatigue
Overview
- Phase
- Phase 4
- Intervention
- Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol
- Conditions
- Fatigue
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 166
- Locations
- 1
- Primary Endpoint
- Rate of subjects whose CIS score has improved under 76 at week 4
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'Ursa Complex Soft Cap. (UDCA-004)' in patients with physical fatigue.
Investigators
Eligibility Criteria
Inclusion Criteria
- •CIS greater than or equal to 76, HADS less than or equal to 10
Exclusion Criteria
- •Subjects who have diseases that can cause fatigue
- •Subjects who are taking medication that can cause fatigue
Arms & Interventions
UDCA004
UDCA004
Intervention: Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol
Placebo of UDCA004
Placebo of UDCA004
Intervention: Placebo
Outcomes
Primary Outcomes
Rate of subjects whose CIS score has improved under 76 at week 4
Time Frame: 4 weeks
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 PreventionCOVID-19NCT05305560MedinCell S.A400
Terminated
Phase 3
A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe PruritusChronic Kidney DiseasesPruritusNCT05342623Cara Therapeutics, Inc.286
Terminated
Phase 3
CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe PruritusChronic Kidney DiseasesPruritusNCT05356403Cara Therapeutics, Inc.105
Completed
Phase 2
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe PruritusChronic Kidney DiseasesPruritusNCT03617536Cara Therapeutics, Inc.269
Terminated
Phase 2
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe PruritusCholestatic PruritusNCT03995212Cara Therapeutics, Inc.14