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

Dr. Falk Pharma

Status and phase: Completed; Phase 4

Conditions: Primary Biliary Cirrhosis

Treatments: Drug: UDCA (Ursodeoxycholic acid)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01510860

URT-15/PBC

Details and patient eligibility

About

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).

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups

Ursodeoxycholic acid (UDCA)250 mg

Active Comparator group

Description:

UDCA 250 mg capsule

Treatment:

Drug: UDCA (Ursodeoxycholic acid)

Drug: UDCA (Ursodeoxycholic acid)

Ursodeoxycholic acid (UDCA)500 mg

Experimental group

Description:

UDCA 500 mg tablet

Treatment:

Drug: UDCA (Ursodeoxycholic acid)

Drug: UDCA (Ursodeoxycholic acid)