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

Phase 4

Completed

• Conditions: Primary Biliary Cirrhosis
• Interventions: Drug: UDCA (Ursodeoxycholic acid)

• Registration Number: NCT01510860
• Lead Sponsor: Dr. Falk Pharma GmbH

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-01
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ursodeoxycholic acid (UDCA)250 mg	UDCA (Ursodeoxycholic acid)	UDCA 250 mg capsule
Ursodeoxycholic acid (UDCA)500 mg	UDCA (Ursodeoxycholic acid)	UDCA 500 mg tablet

Primary Outcome Measures

Name	Time	Method
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.	Between baseline and week 24

Secondary Outcome Measures

Name	Time	Method
Quality of Life	Between baseline and week 24

Trial Locations

Locations (1)

Klinikum Grosshadern; 🇩🇪 Munich, Germany