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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01510860
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : May 7, 2019
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Brief 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).

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: UDCA (Ursodeoxycholic acid) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Active Comparator: Ursodeoxycholic acid (UDCA)250 mg
UDCA 250 mg capsule
Drug: UDCA (Ursodeoxycholic acid)
250 mg

Experimental: Ursodeoxycholic acid (UDCA)500 mg
UDCA 500 mg tablet
Drug: UDCA (Ursodeoxycholic acid)
500 mg

Primary Outcome Measures :
  1. 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. [ Time Frame: Between baseline and week 24 ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Between baseline and week 24 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01510860

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Klinikum Grosshadern
Munich, Germany, 81377
Sponsors and Collaborators
Dr. Falk Pharma GmbH
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Principal Investigator: Christian Rust, MD Klinikum Grosshadern Munich
Publications of Results:
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Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT01510860    
Other Study ID Numbers: URT-15/PBC
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: January 2012
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Biliary
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Bile Duct Diseases
Biliary Tract Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents