The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis
1 other identifier
interventional
56
1 country
1
Brief Summary
The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 31, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2022
CompletedMarch 16, 2022
March 1, 2022
2.1 years
August 31, 2019
March 15, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Fibro-scan score
change in liver stiffness measurement (Fibro-scan score)
At baseline and after 12 weeks of intervention
Liver Panel
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
after 12 weeks of intervention
Secondary Outcomes (6)
HOMA-IR
after 12 weeks of intervention
8-OHdG
after 12 weeks of intervention
TNF-Alpha
after 12 weeks of intervention
hyaluronic acid
after 12 weeks of intervention
TGF-β1
after 12 weeks of intervention
- +1 more secondary outcomes
Study Arms (2)
Control group
PLACEBO COMPARATOR26 patients will receive placebo (Control group)
Montelukast group
EXPERIMENTAL26 patients will receive montelukast 10 mg/ day
Interventions
patients received matching-image placebo once daily at bedtime for 12 weeks.
patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine
Shibīn al Kawm, Menoufia, 13829, Egypt
Related Publications (1)
Abdallah MS, Eldeen AH, Tantawy SS, Mostafa TM. The leukotriene receptor antagonist montelukast in the treatment of non-alcoholic steatohepatitis: A proof-of-concept, randomized, double-blind, placebo-controlled trial. Eur J Pharmacol. 2021 Sep 5;906:174295. doi: 10.1016/j.ejphar.2021.174295. Epub 2021 Jun 30.
PMID: 34214585DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Clinical Pharmacy, PhD.
Study Record Dates
First Submitted
August 31, 2019
First Posted
September 6, 2019
Study Start
August 1, 2019
Primary Completion
August 31, 2021
Study Completion
March 15, 2022
Last Updated
March 16, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF