NCT01510860

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
Last Updated

May 7, 2019

Status Verified

January 1, 2012

Enrollment Period

1.7 years

First QC Date

January 12, 2012

Last Update Submit

May 3, 2019

Conditions

Primary Biliary Cirrhosis

Outcome Measures

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.

    Between baseline and week 24

Secondary Outcomes (1)

  • Quality of Life

    Between baseline and week 24

Study Arms (2)

Ursodeoxycholic acid (UDCA)250 mg

ACTIVE COMPARATOR

UDCA 250 mg capsule

Drug: UDCA (Ursodeoxycholic acid)

Ursodeoxycholic acid (UDCA)500 mg

EXPERIMENTAL

UDCA 500 mg tablet

Drug: UDCA (Ursodeoxycholic acid)

Interventions

UDCA (Ursodeoxycholic acid)DRUG

250 mg

Ursodeoxycholic acid (UDCA)250 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Negative pregnancy
  • Signed informed consent
  • Histologically proven non-cirrhotic liver disease

You may not qualify if:

  • histologically proven cirrhosis
  • PBC stage II+IV
  • Positive HIV serology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Grosshadern

Munich, 81377, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27121784RESULT

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Officials

  • Christian Rust, MD

    Klinikum Grosshadern Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 18, 2012

Study Start

November 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

May 7, 2019

Record last verified: 2012-01

Locations

DE(1)