Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis

Primary Biliary Cirrhosis Clinical Trial

Official title:

Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510860
• Other study ID #: URT-15/PBC
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: July 2010

Study information

• Verified date: January 2012
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Negative pregnancy

• Signed informed consent

• Histologically proven non-cirrhotic liver disease

Exclusion Criteria:

• histologically proven cirrhosis

• PBC stage II+IV

• Positive HIV serology

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• UDCA (Ursodeoxycholic acid)
250 mg
• UDCA (Ursodeoxycholic acid)
500 mg

Locations

Country	Name	City	State
Germany	Klinikum Grosshadern	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of liver enzymes between baseline and the end of the treatment-period with Ursofalk 250 mg capsules and the end of treatment-period with Ursofalk 500 mg tablets.		Between baseline and week 24
Secondary	Quality of Life		Between baseline and week 24