Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine

University of Sao Paulo General Hospital

Status: Completed

Conditions: Ursodeoxycholic Acid; Primary Biliary Cirrhosis

Treatments: Drug: Ursodeoxycholic Acid 300mg tablet; Drug: Ursodeoxycholic Acid 300mg capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03489889

Gastro FMUSP

Details and patient eligibility

About

A manipulation and an integral part of the pharmaceutical practice, where, in addition to the supply of medicines and personalized products, they represent an alternative to the therapeutic schemes, manipulating drugs of almost all of them as therapeutic categories.

One of the products and ursodeoxycholic acid, commercially known as Ursacol, a bile acid physiologically present in human bile, approved by Agência Nacional de Vigilância Sanitária (ANVISA), among several indications, for the treatment of the symptomatic form of primary biliary cholangitis, autoimmune etiology and predominant incidence in female.

This is a prospective, cross-over, interventional and open-label study, where patients attending the inclusion and exclusion criteria are attended by the Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (ICHC-FMUSP) Pharmacy Division in the Pharmaceutical Care sector.

As patient information as well as the prescribed drugs, compiled by a data collection instrument from the ICHC-FMUSP Pharmacy Division and a semi-structured questionnaire.

Full description

The therapeutic efficacy of Ursodeoxycholic Acid 300 mg tablet and capsules was measured comparing the liver enzyme parameters: alkaline phosphatase, gamma glutamyl transferase, alanine aminotransferase, aspartate aminotransferase and total bilirubin in three times: before treatment begins, in the middle of treatment and at the end of treatment.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Primary biliary cholangitis (PBC) was diagnosed when at least two of the following three criteria: histologically proven early stage PBC; positive Anti-mitochondrial antibody (AMA) (titer >1:40) and alkaline phosphatase >1.5 times upper limit of normal at any time since diagnosis.
• Patients had to be on ursodeoxycholic acid for at least 6 months.
• Patients should be able to understand and ready to sign the informed consent form.

Exclusion criteria

• Patients not adherent to treatment with reference medicine.
• Known intolerance to the study drugs.
• Patients who withdrew their agreement.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

capsule

Experimental group

Description:

pharmaceutical form: capsule ursodeoxycholic acid 300 mg 13-15mg/kg day 3 months

Treatment:

Drug: Ursodeoxycholic Acid 300mg capsule

tablet

Experimental group

Description:

pharmaceutical form: tablet ursodeoxycholic acid 300 mg 13-15mg/kg day 3 months

Treatment:

Drug: Ursodeoxycholic Acid 300mg tablet