Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
NCT01510860 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2019-05-07
Summary
The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).
Conditions
- Primary Biliary Cirrhosis
Interventions
- DRUG
-
UDCA (Ursodeoxycholic acid)
250 mg
- DRUG
-
UDCA (Ursodeoxycholic acid)
500 mg
Sponsors & Collaborators
-
Dr. Falk Pharma GmbH
lead INDUSTRY
Principal Investigators
-
Christian Rust, MD · Klinikum Grosshadern Munich
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2010-07-31
- Completion
- 2010-07-31
Countries
- Germany
Study Locations
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