Skip to main content
OpenTrials
Completed

NCT Number: NCT01510860

Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Biliary Cirrhosis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinikum Grosshadern

Munich, 81377, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UDCA (Ursodeoxycholic acid)

Drug

250 mg

Primary outcomes

  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 outcomes

  1. Quality of Life

    Time frame: Between baseline and week 24

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 18, 2012
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.