NCT02464124 is a Phase 2/Phase 3 clinical trial of Nitazoxanide in Encephalopathy, Hepatic, sponsored by Sherief Abd-Elsalam.

Who is sponsoring NCT02464124?

NCT02464124 is sponsored by Sherief Abd-Elsalam.

What drugs are being tested in NCT02464124?

Interventions in NCT02464124: Nitazoxanide, Lactulose.

What condition does NCT02464124 study?

NCT02464124 studies Encephalopathy, Hepatic.

Is NCT02464124 still recruiting?

NCT02464124 is currently status unknown. Last updated 16 August 2017.

Last reviewed 2017-08-16 · How we verify

NCT02464124

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-blind, Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone Treatment of Overt Hepatic Encephalopathy

Status unknown Phase 2/Phase 3 Last updated 16 August 2017

What this trial tests

Phase 2/Phase 3 trial testing Nitazoxanide in Encephalopathy, Hepatic in 120 participants. Status unknown.

Timeline

1 January 2016

Primary endpoint
1 December 2017

1 December 2017

Quick facts

Lead sponsor	Sherief Abd-Elsalam
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	120
Start date	1 January 2016
Primary completion	1 December 2017
Estimated completion	1 December 2017
Sites	1 location across Egypt

Drugs / interventions tested

Nitazoxanide (NITAZOXANIDE) — full drug profile →
Lactulose (LACTULOSE) — full drug profile →

Conditions studied

Encephalopathy, Hepatic — all drugs for Encephalopathy, Hepatic →

Sponsor

Sherief Abd-Elsalam — full company profile →

Who can join

Adults 18 to 70, any sex, with Encephalopathy, Hepatic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of patients with total reversal of hepatic encephalopathy
Time frame: 6 months

Sponsor's own description

Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with chronic and acute liver dysfunction. It is characterized by cognitive and motor deficits of varying severity. Treatment options include lactulose administered orally or by nasogastric tube or enema, non-absorbable antibiotics, and protein-restricted diets. Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented a pilot prospective study at the 2008 American Association for the Study of Liver Diseases meeting showing clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

UEG Week 2017 Oral Presentations
· 2017

Verify or expand the search:

Other trials of Nitazoxanide

Trials testing the same drug.

NCT06993974 — Nitazoxanide in Patients With Ulcerative Colitis · Phase 2 · recruiting
NCT07086937 — Efficacy of Nitazoxanide Based Therapy vs Standard Triple Therapy in H-pylori in Children · NA · completed
NCT06010992 — Nitazoxanide as Adjuvant Therapy in Type 2 Diabetes Mellitus · Phase 2 · unknown
NCT05368935 — Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects · Phase 1 · completed
NCT05116826 — Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients · Phase 1 · completed

Other Sherief Abd-Elsalam trials

Trials by the same sponsor.

NCT05291455 — Lacosamide in Neonatal Status Epilepticus · Phase 3 · unknown
NCT04766177 — Role of Bumetanide in Treatment of Autism · Phase 3 · recruiting
NCT04499755 — Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics · Phase 3 · recruiting
NCT04499885 — Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning · NA · recruiting
NCT04216199 — Role of Point of Care Ultrasound in Endotracheal Tube Placement · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02464124 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sherief Abd-Elsalam
Last refreshed: 16 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02464124.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing