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

This study has been completed.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH Identifier:
First received: January 12, 2012
Last updated: January 17, 2012
Last verified: January 2012
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 Intervention Phase
Primary Biliary Cirrhosis Drug: UDCA (Ursodeoxycholic acid) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • 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:
  • Quality of Life [ Time Frame: Between baseline and week 24 ]

Enrollment: 65
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01510860

Klinikum Grosshadern
Munich, Germany, 81377
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Principal Investigator: Christian Rust, MD Klinikum Grosshadern Munich
  More Information

Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT01510860     History of Changes
Other Study ID Numbers: URT-15/PBC
Study First Received: January 12, 2012
Last Updated: January 17, 2012

Additional relevant MeSH terms:
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 processed this record on September 20, 2017