NCT04537780 is a Phase 4 clinical trial of Montelukast in Non Alcoholic Steatohepatitis, sponsored by Tanta University.

Who is sponsoring NCT04537780?

NCT04537780 is sponsored by Tanta University.

What drugs are being tested in NCT04537780?

Interventions in NCT04537780: Placebo, Montelukast.

What condition does NCT04537780 study?

NCT04537780 studies Non Alcoholic Steatohepatitis.

Is NCT04537780 still recruiting?

NCT04537780 is currently completed. Last updated 3 September 2020.

Last reviewed 2020-09-03 · How we verify

NCT04537780

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

Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)

Completed Phase 4 Last updated 3 September 2020

What this trial tests

Phase 4 trial testing Placebo in Non Alcoholic Steatohepatitis in 44 participants. Completed in 30 August 2020.

Timeline

20 August 2019

Primary endpoint
30 August 2020

30 August 2020

Quick facts

Lead sponsor	Tanta University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	44
Start date	20 August 2019
Primary completion	30 August 2020
Estimated completion	30 August 2020
Sites	1 location across Egypt

Drugs / interventions tested

Placebo
Montelukast (montelukast) — full drug profile →

Conditions studied

Non Alcoholic Steatohepatitis — all drugs for Non Alcoholic Steatohepatitis →

Sponsor

Tanta University

Who can join

Adults 20 to 70, any sex, with Non Alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

the current study is to evaluate the efficacy and safety of Montelukast in the treatment of patients with non-alcoholic steatohepatitis (NASH).

Publications & conference data

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

The role of extracellular vesicles in non-alcoholic steatohepatitis: Emerging mechanisms, potential therapeutics and biomarkers.
Wang Q, Tang X, Wang Y, Zhang D, et al · · 2025 · cited 5× · PMID 38494073 · DOI 10.1016/j.jare.2024.03.009

Verify or expand the search:

Other trials of Montelukast

Trials testing the same drug.

NCT07320625 — Efficacy of Montelukast on STEMl Patients · Phase 3 · recruiting
NCT07101445 — Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injecti · Phase 4 · recruiting
NCT06356571 — A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Partici · Phase 2 · recruiting
NCT05922761 — BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) · Phase 2 · recruiting
NCT05896228 — Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma · Phase 2 · recruiting

Other recruiting trials for Non Alcoholic Steatohepatitis

Currently open trials in the same condition.

NCT06676813 — Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis. · NA · recruiting
NCT05463796 — InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer · recruiting
NCT05821010 — Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis · Phase 2 · recruiting
NCT05574036 — Comparative Study Between Febuxostat Versus Vitamin E in Non-alcoholic Steatohepatitis Patients With Hyperuricemia · Phase 2 · active not recruiting

Other Tanta University trials

Trials by the same sponsor.

NCT07398651 — Apremilast and Adalimumab in Psoriatic Arthritis Patients · NA · not yet recruiting
NCT06966856 — This Randomized, Clinical Trial Evaluates the Efficacy of Oral Versus Sublingual Vitamin B12 Supplementation in Correcti · Phase 3 · not yet recruiting
NCT07334197 — Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy · NA · not yet recruiting
NCT07498998 — Glucocorticoid, Ozone and 5% Dextrose Local Injection for Pain Relief in Carpal Tunnel Syndrome · NA · not yet recruiting
NCT07114250 — Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Supine Percutaneous Nephrolithotomy Operation · NA · not yet 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 NCT04537780 (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 Tanta University
Last refreshed: 3 September 2020

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/NCT04537780.

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