NCT02334163

Brief Summary

Evaluating the efficacy and safety of nitazoxanide in comparison to standard treatment in patients with grade II-III hepatic encephalopathy (HE). Also, Evaluating the effect of administering nitazoxanide on the improvement of patient's quality of life.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

January 6, 2015

Last Update Submit

January 7, 2015

Conditions

Hepatic Encephalopathy

Keywords

Hepatic EncephalopathyNitazoxanideSerum ammonia

Outcome Measures

Primary Outcomes (1)

  • Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score)

    evaluating the efficacy by measuring serum ammonia and calculating CHESS score at baseline and at end of treatment

    7 days

Secondary Outcomes (2)

  • Evaluating the safety of nitazoxanide (estimation of treatment- related undesirable effects)

    37 days

  • Effect of nitazoxanide on patient's quality of life (CLDQ score)

    7 days

Study Arms (3)

Nitazoxanide group

EXPERIMENTAL

12 patients will receive the following for 7 days: * Oral lactulose * 500 mg nitazoxanide tablets twice daily

Drug: NitazoxanideDrug: Oral lactulose

Metronidazole group

ACTIVE COMPARATOR

12 patients will receive the following for 7 days: * Oral lactulose * 250 mg metronidazole tablets every 8 hours

Drug: Oral lactuloseDrug: Metronidazole

Rifaximine group

ACTIVE COMPARATOR

12 patients will receive the following for 7 days: * Oral lactulose * Two 200 mg rifaximine tablets every 8 hours

Drug: Oral lactuloseDrug: Rifaximine

Interventions

NitazoxanideDRUG

500 mg nitazoxanide tablets twice daily

Nitazoxanide group
Oral lactuloseDRUG

Oral lactulose (65%)

Metronidazole groupNitazoxanide groupRifaximine group
MetronidazoleDRUG

250 mg metronidazole tablets every 8 hours

Metronidazole group
RifaximineDRUG

Two 200 mg rifaximine tablets every 8 hours

Rifaximine group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Patients from 18 to 65 years.
  • Patients with grade II-III Hepatic Encephalopathy.

You may not qualify if:

  • Patients with active GIT bleeding.
  • Patients with major psychiatric illness.
  • Patients receiving benzodiazepines, narcotics, alcohol and marijuana.
  • Patients with compromised renal or biliary functions.
  • Patients known to have AIDS.
  • Patients receiving medications highly bound to plasma proteins eg. Warfarin.
  • Patients with known hypersensitivity to nitazoxanide.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Ain Shams University

Cairo, 1156, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

nitazoxanideLactuloseMetronidazoleRifaximin

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Asmaa A. Elrakaybi, Bachelor

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal T. Abd ElMoez, PhD

CONTACT

d_amal_tohamy@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 8, 2015

Study Start

December 1, 2014

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

EG(1)