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

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.

Study Overview

• Status: Completed
• Conditions: Primary Biliary Cirrhosis; Ursodeoxycholic Acid
• Intervention / Treatment: Drug: Ursodeoxycholic Acid 300mg capsule; Drug: Ursodeoxycholic Acid 300mg tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: capsule; 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
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic efficacy between capsule and tablet	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.	up to 12 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Publications and helpful links

General Publications

• Nakano LA, Cancado ELR, Chaves CE, Madeira MCV, Katayose JT, Nabeshima MA, Fossaluza V, Uhrigshardt GG, Liting Z, Pinto VB, Carrilho FJ, Ono SK. A randomized crossover trial to assess therapeutic efficacy and cost reduction of acid ursodeoxycholic manufactured by the university hospital for the treatment of primary biliary cholangitis. BMC Gastroenterol. 2020 Aug 5;20(1):253. doi: 10.1186/s12876-020-01399-5.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Liver Cirrhosis, Biliary; Ursodeoxycholic Acid
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Fibrosis; Liver Cirrhosis, Biliary; Gastrointestinal Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid
• Other Study ID Numbers: Gastro FMUSP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No