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

NCT03489889 | Completed DMC

• 1 other identifier: Gastro FMUSP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ursodeoxycholic Acid; Primary Biliary Cirrhosis

Keywords

Liver Cirrhosis, Biliary; Ursodeoxycholic Acid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

capsule

EXPERIMENTAL

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

Drug: Ursodeoxycholic Acid 300mg capsule

tablet

EXPERIMENTAL

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

Drug: Ursodeoxycholic Acid 300mg tablet

Interventions

Ursodeoxycholic Acid 300mg tablet DRUG

Cross-over study: Ursodeoxycholic Acid 300mg tablet and after Ursodeoxycholic Acid 300mg capsule

tablet

Ursodeoxycholic Acid 300mg capsule DRUG

Cross-over study: Ursodeoxycholic Acid 300mg capsule and after Ursodeoxycholic Acid 300mg tablet

capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 32758152 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Ursodeoxycholic Acid; Tablets

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: April 6, 2018
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

BR (1)