Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 12, 2012
January 17, 2012
November 2008
July 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01510860 on ClinicalTrials.gov Archive Site
Quality of Life [ Time Frame: Between baseline and week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
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

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Biliary Cirrhosis
  • Drug: UDCA (Ursodeoxycholic acid)
    250 mg
  • Drug: UDCA (Ursodeoxycholic acid)
    500 mg
  • Active Comparator: Ursodeoxycholic acid (UDCA)250 mg
    UDCA 250 mg capsule
    Intervention: Drug: UDCA (Ursodeoxycholic acid)
  • Experimental: Ursodeoxycholic acid (UDCA)500 mg
    UDCA 500 mg tablet
    Intervention: Drug: UDCA (Ursodeoxycholic acid)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01510860
URT-15/PBC
Yes
Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
Not Provided
Principal Investigator: Christian Rust, MD Klinikum Grosshadern Munich
Dr. Falk Pharma GmbH
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP