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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
Sponsor:
Information provided by (Responsible Party):
Cleuber Esteves Chaves, University of Sao Paulo General Hospital

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.

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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


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




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.



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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.

Information from the National Library of Medicine

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


Locations
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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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:
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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