Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04161053

Collaborator

(none)

Enrollment

Location

Arms

121

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatic Encephalopathy	Drug: Rifaximin Drug: Nitazoxanide	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Nov 1, 2028

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of encephalopathy episodes during treatment [6 months]
The number of encephalopathy episodes during treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sherief Abd-Elsalam	Tanta		Egypt

Sponsors and Collaborators

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