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

May 3, 2019 updated by: Dr. Falk Pharma GmbH

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81377
        • Klinikum Großhadern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ursodeoxycholic acid (UDCA)250 mg
UDCA 250 mg capsule
Drug: UDCA (Ursodeoxycholic acid)
250 mg
Drug: UDCA (Ursodeoxycholic acid)
500 mg
Experimental: Ursodeoxycholic acid (UDCA)500 mg
UDCA 500 mg tablet
Drug: UDCA (Ursodeoxycholic acid)
250 mg
Drug: UDCA (Ursodeoxycholic acid)
500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Between baseline and week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: Between baseline and week 24
Between baseline and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Principal Investigator: Christian Rust, MD, Klinikum Grosshadern Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 18, 2012

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URT-15/PBC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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