Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

November 12, 2019 updated by: Sherief Abd-Elsalam, Tanta University

Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cirrhotic patient with at least one previous episode of hepatic encephalopathy.
  • Adult Patients aging from 20 to 65 years old

Exclusion Criteria:

  • Active GIT bleeding.
  • Major psychiatric illness (psychosis & epilepsy).
  • Renal insufficiency (S.Cr 2mg/dl).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Rifaximin
550 mg Rifaximin tablets twice daily for six months.
Drug: Rifaximin
Rifaximin 550 mg twice daily for 6 months
Other Names:
  • Gastrobiotic, Trencedia
EXPERIMENTAL: Nitazoxanide
500 mg Nitazoxanide tablets twice daily for six months.
Drug: Nitazoxanide
Nitazoxanide 500 mg twice daily for 6 months
Other Names:
  • Nanazoxid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of encephalopathy episodes during treatment
Time Frame: 6 months
The number of encephalopathy episodes during treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Khadija Ahmed Glal, Msc, faculty of pharmacy- Tanta University
  • Principal Investigator: Tarek Mohamed Mostafa, ass, Prof., faculty of pharmacy- Tanta University
  • Principal Investigator: Sherief Abd-Elsalam, Ass. Prof., Tanta University - Tropical Medicine Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ANTICIPATED)

November 1, 2028

Study Completion (ANTICIPATED)

December 1, 2028

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (ACTUAL)

November 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Encephalopathy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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