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

Primary Purpose

Primary Biliary Cirrhosis

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

UDCA (Ursodeoxycholic acid)

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinikum Grosshadern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ursodeoxycholic acid (UDCA)250 mg

Ursodeoxycholic acid (UDCA)500 mg

Arm Description

UDCA 250 mg capsule

UDCA 500 mg tablet

Outcomes

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.

Secondary Outcome Measures

Quality of Life

Full Information

NCT ID

NCT01510860

First Posted

January 12, 2012

Last Updated

May 3, 2019

Sponsor

Dr. Falk Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01510860

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Biliary Cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ursodeoxycholic acid (UDCA)250 mg

Arm Type

Active Comparator

Arm Description

UDCA 250 mg capsule

Arm Title

Ursodeoxycholic acid (UDCA)500 mg

Arm Type

Experimental

Arm Description

UDCA 500 mg tablet

Intervention Type

Drug

Intervention Name(s)

UDCA (Ursodeoxycholic acid)

Intervention Description

250 mg

Intervention Type

Drug

Intervention Name(s)

UDCA (Ursodeoxycholic acid)

Intervention Description

500 mg

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Quality of Life

Time Frame

Between baseline and week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Rust, MD

Organizational Affiliation

Klinikum Grosshadern Munich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinikum Grosshadern

City

Munich

ZIP/Postal Code

81377

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

27121784

Citation

Hopf C, Grieshaber R, Hartmann H, Hinrichsen H, Eisold M, Cordes HJ, Greinwald R, Rust C. Therapeutic Equivalence of Ursodeoxycholic Acid Tablets and Ursodeoxycholic Acid Capsules for the Treatment of Primary Biliary Cirrhosis. Clin Pharmacol Drug Dev. 2013 Jul;2(3):231-6. doi: 10.1002/cpdd.24. Epub 2013 Apr 15. No abstract available.

Results Reference

result

Learn more about this trial

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

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