NCT03489889

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ursodeoxycholic Acid
• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	Ursodeoxycholic Acid 300mg tablet	Cross-over study: Ursodeoxycholic Acid 300mg tablet and after Ursodeoxycholic Acid 300mg capsule
DRUG	Ursodeoxycholic Acid 300mg capsule	Cross-over study: Ursodeoxycholic Acid 300mg capsule and after Ursodeoxycholic Acid 300mg tablet

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-01
• Completion: 2018-06-01
• First posted: 2018-04-06
• Last updated: 2018-10-11

Locations

1 site across 1 country: Brazil