Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine
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|ClinicalTrials.gov Identifier: NCT03489889|
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : October 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Ursodeoxycholic Acid Primary Biliary Cirrhosis||Drug: Ursodeoxycholic Acid 300mg tablet Drug: Ursodeoxycholic Acid 300mg capsule||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||June 2018|
pharmaceutical form: capsule ursodeoxycholic acid 300 mg 13-15mg/kg day 3 months
Drug: Ursodeoxycholic Acid 300mg capsule
Cross-over study: Ursodeoxycholic Acid 300mg capsule and after Ursodeoxycholic Acid 300mg tablet
pharmaceutical form: tablet ursodeoxycholic acid 300 mg 13-15mg/kg day 3 months
Drug: Ursodeoxycholic Acid 300mg tablet
Cross-over study: Ursodeoxycholic Acid 300mg tablet and after Ursodeoxycholic Acid 300mg capsule
- Therapeutic efficacy between capsule and tablet [ Time Frame: up to 12 months ]Compare the liver enzyme parameters (alkaline phosphatase, alanine aminotranferase, aspartate aminotransferase, gamma glutamyl transferase and total bilirubin) in three different moments:before the treatment, between the treatment and at the end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489889
|Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo|
|São Paulo, Brazil, 05403-000|