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The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis

Primary Purpose

Steatohepatitis, Nonalcoholic

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Control group

Montelukast group

About this trial

This is an interventional treatment trial for Steatohepatitis, Nonalcoholic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- The inclusion criteria were adult patients (age >18 years old) of both sexes, overweight/obese subjects with presence of evidence of hepatic steatosis by imaging (increased liver echogenicity, stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins). Patients with mild to moderate elevation in aminotransferase activities (> 2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, Fibro-scan score >7 kpa and <12.5 kpa (F0-F3), and HAIR score of 2 or 3 were included in the study.

Exclusion Criteria:

- The exclusion criteria included smokers, patients with secondary hepatic fat accumulation which results from using steatogenic medications or hereditary disorders. Alcohol consumers, patients with Wilson's disease, hemochromatosis, viral hepatitis, decompensated liver disease, inflammatory diseases, diabetes, depression and patients with other comorbid conditions that elevate transaminases (congestive heart failure and malignancy) pregnancy and lactating women were excluded

Sites / Locations

Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Montelukast group

Arm Description

26 patients will receive placebo (Control group)

26 patients will receive montelukast 10 mg/ day

Outcomes

Primary Outcome Measures

Fibro-scan score

change in liver stiffness measurement (Fibro-scan score)

Liver Panel

Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L

Secondary Outcome Measures

HOMA-IR

Homeostatic Model Assessment of Insulin Resistance

8-OHdG

Serum level of 8-OHdG

TNF-Alpha

Serum level of TNF-Alpha

hyaluronic acid

Serum level of hyaluronic acid

TGF-β1

Serum level of TGF-β1

Assessment of drugs tolerability: Side effects

Side effects of montelukast

Full Information

NCT ID

NCT04080947

First Posted

August 31, 2019

Last Updated

March 15, 2022

Sponsor

Sadat City University

1. Study Identification

Unique Protocol Identification Number

NCT04080947

Brief Title

The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis

Official Title

The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sadat City University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Steatohepatitis, Nonalcoholic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

26 patients will receive placebo (Control group)

Arm Title

Montelukast group

Arm Type

Experimental

Arm Description

26 patients will receive montelukast 10 mg/ day

Intervention Type

Drug

Intervention Name(s)

Control group

Intervention Description

patients received matching-image placebo once daily at bedtime for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Montelukast group

Intervention Description

patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.

Primary Outcome Measure Information:

Title

Fibro-scan score

Description

change in liver stiffness measurement (Fibro-scan score)

Time Frame

At baseline and after 12 weeks of intervention

Title

Liver Panel

Description

Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L

Time Frame

after 12 weeks of intervention

Secondary Outcome Measure Information:

Title

HOMA-IR

Description

Homeostatic Model Assessment of Insulin Resistance

Time Frame

after 12 weeks of intervention

Title

8-OHdG

Description

Serum level of 8-OHdG

Time Frame

after 12 weeks of intervention

Title

TNF-Alpha

Description

Serum level of TNF-Alpha

Time Frame

after 12 weeks of intervention

Title

hyaluronic acid

Description

Serum level of hyaluronic acid

Time Frame

after 12 weeks of intervention

Title

TGF-β1

Description

Serum level of TGF-β1

Time Frame

after 12 weeks of intervention

Title

Assessment of drugs tolerability: Side effects

Description

Side effects of montelukast

Time Frame

after 12 weeks of intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - The inclusion criteria were adult patients (age >18 years old) of both sexes, overweight/obese subjects with presence of evidence of hepatic steatosis by imaging (increased liver echogenicity, stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins). Patients with mild to moderate elevation in aminotransferase activities (> 2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, Fibro-scan score >7 kpa and <12.5 kpa (F0-F3), and HAIR score of 2 or 3 were included in the study. Exclusion Criteria: - The exclusion criteria included smokers, patients with secondary hepatic fat accumulation which results from using steatogenic medications or hereditary disorders. Alcohol consumers, patients with Wilson's disease, hemochromatosis, viral hepatitis, decompensated liver disease, inflammatory diseases, diabetes, depression and patients with other comorbid conditions that elevate transaminases (congestive heart failure and malignancy) pregnancy and lactating women were excluded

Facility Information:

Facility Name

Faculty of Medicine

City

Shibīn Al Kawm

State/Province

Menoufia

ZIP/Postal Code

13829

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

34214585

Citation

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.

Results Reference

derived

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The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis

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