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

• ClinicalTrials.gov Identifier: NCT03489889
• Recruitment Status: Completed
• First Posted: April 6, 2018
• Last Update Posted: October 11, 2018
• Sponsor: University of Sao Paulo General Hospital
• Information provided by (Responsible Party): Cleuber Esteves Chaves, University of Sao Paulo General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ursodeoxycholic Acid; Primary Biliary Cirrhosis	Drug: Ursodeoxycholic Acid 300mg tablet; Drug: Ursodeoxycholic Acid 300mg capsule	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

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

São Paulo, Brazil, 05403-000

Sponsors and Collaborators

University of Sao Paulo General Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nakano LA, Cançado 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.

• Responsible Party: Cleuber Esteves Chaves, Principal Investigator, University of Sao Paulo General Hospital
• ClinicalTrials.gov Identifier: NCT03489889
• Other Study ID Numbers: Gastro FMUSP
• First Posted: April 6, 2018
• Last Update Posted: October 11, 2018
• Last Verified: October 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cleuber Esteves Chaves, University of Sao Paulo General Hospital:

Liver Cirrhosis, Biliary; Ursodeoxycholic Acid

Additional relevant MeSH terms:

Liver Cirrhosis, Biliary; Fibrosis; Pathologic Processes; Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Ursodeoxycholic Acid; Cholagogues and Choleretics; Gastrointestinal Agents