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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.
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01510860
First received: January 12, 2012
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Cirrhosis
Drug Information available for: Ursodiol
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Between baseline and week 24 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510860

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

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01510860     History of Changes
Other Study ID Numbers: URT-15/PBC
Study First Received: January 12, 2012
Last Updated: January 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Liver Cirrhosis, Biliary
Liver Cirrhosis
Fibrosis
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
 Liver Diseases
Pathologic Processes
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013