Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
NCT ID: NCT01510860
Last Updated: 2019-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
65 participants
INTERVENTIONAL
2008-11-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ursodeoxycholic acid (UDCA)250 mg
UDCA 250 mg capsule
UDCA (Ursodeoxycholic acid)
250 mg
Ursodeoxycholic acid (UDCA)500 mg
UDCA 500 mg tablet
UDCA (Ursodeoxycholic acid)
500 mg
Interventions
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UDCA (Ursodeoxycholic acid)
250 mg
UDCA (Ursodeoxycholic acid)
500 mg
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* Histologically proven non-cirrhotic liver disease
Exclusion Criteria
* PBC stage II+IV
* Positive HIV serology
18 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Christian Rust, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Grosshadern Munich
Locations
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Klinikum Grosshadern
Munich, , Germany
Countries
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References
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Hopf C, Grieshaber R, Hartmann H, Hinrichsen H, Eisold M, Cordes HJ, Greinwald R, Rust C. Therapeutic Equivalence of Ursodeoxycholic Acid Tablets and Ursodeoxycholic Acid Capsules for the Treatment of Primary Biliary Cirrhosis. Clin Pharmacol Drug Dev. 2013 Jul;2(3):231-6. doi: 10.1002/cpdd.24. Epub 2013 Apr 15. No abstract available.
Other Identifiers
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URT-15/PBC
Identifier Type: -
Identifier Source: org_study_id
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