Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine
Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
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.