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

Primary Purpose

Non Alcoholic Steatohepatitis

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Placebo

Montelukast

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult (>18 years) overweight/obese subjects who have persistently abnormal aminotransferase level in two separate occasions over the past six months.

NAFLD will be assumed in patients with moderately elevated aminotransferase activities (<3x the upper limit of normal).

There is evidence of hepatic steatosis by imaging (increased liver echogenicity (bright), stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins) and there is no cause for secondary hepatic fat accumulation such as significant alcohol consumption, use of steatogenic medication or hereditary disorders. Patients with fibroscan score >7 kPa and <14 kPa will be included in the study.

Exclusion Criteria:

Alcohol abusers.
Presence of evidence for viral or autoimmune hepatitis.
Diabetic patients.
Patients with Wilson's disease and patients with hemochromatosis.
Patients with decompensated liver disease.
Patients show hypersensitivity to studied medications.
Patients taking medication known to cause steatosis.
Patients with other comorbid conditions that could potentially elevate transaminase, such as congestive heart failure, malignancy.
Pregnancy and lactating women.

Sites / Locations

Dr. Tarek Mohamed Mostafa

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

group 1

Group 2

Arm Description

(Control group n= 22): Patients will receive Placebo once daily at bedtime for 12 weeks..

Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime. The treatment duration will be 12 weeks.

Outcomes

Primary Outcome Measures

serum 8-Hydroxy2-deoxyguanisine (8-OHdG)

Quantitative detection of human 8-OHdG will be done using commercially available Enzyme-linked Immunosorbent assay kits.

TNF-α.

Quantitative detection of TNF-α will be done using commercially available Enzyme-linked Immunosorbent assay kits.

Alanine aminotransferase (ALT).

ALT will be measured by colorimetric method.

Aspartate aminotransferase (AST)

AST will be measured by colorimetric method.

ɤ-glutamyltranspeptidase(GGT)

ɤ-glutamyltranspeptidase(GGT) will be measured by colorimetric method.

Secondary Outcome Measures

Full Information

NCT ID

NCT04537780

First Posted

August 30, 2020

Last Updated

August 30, 2020

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT04537780

Brief Title

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

Official Title

Clinical Study Evaluating the Efficacy and Safety of Montelukast in the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

August 20, 2019 (Actual)

Primary Completion Date

August 30, 2020 (Actual)

Study Completion Date

August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Detailed Description

This is a randomized, prospective placebo-controlled study that will be conducted on 44 patients who fulfill the selection criteria and will be classified randomly into two groups. Group 1 (Control group n= 22): Patients will receive Placebo once daily at bedtime. Group 2 (Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime. The treatment duration will be 12 weeks. Patients will be recruited from National Liver Institute and Fever, Liver and GIT disease Shebin El-Kom hospital, Egypt. All participants will be informed about the nature of the study. The patients will give their informed consent.The study will be approved by Research Ethics Committee of faculty of pharmacy -Tanta University. Data of all patients will be private and confidential. Any unexpected risk will be reported to patients and ethical committee on time

6. Conditions and Keywords

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

Non Alcoholic Steatohepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

randomized, prospective placebo controlled study that will be conducted on 44 patients who fulfill the selection criteria and will be classified randomly into two groups. Group 1 (Control group n= 22): Patients will receive Placebo once daily at bedtime. Group 2 (Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime. The treatment duration will be 12 weeks.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group 1

Arm Type

Placebo Comparator

Arm Description

(Control group n= 22): Patients will receive Placebo once daily at bedtime for 12 weeks..

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime. The treatment duration will be 12 weeks.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo tabled every day

Intervention Type

Drug

Intervention Name(s)

Montelukast

Other Intervention Name(s)

Singulair

Intervention Description

Montelukast 10 mg daily at bed time.

Primary Outcome Measure Information:

Title

serum 8-Hydroxy2-deoxyguanisine (8-OHdG)

Description

Quantitative detection of human 8-OHdG will be done using commercially available Enzyme-linked Immunosorbent assay kits.

Time Frame

12 Weeks

Title

TNF-α.

Description

Quantitative detection of TNF-α will be done using commercially available Enzyme-linked Immunosorbent assay kits.

Time Frame

12 Weeks

Title

Alanine aminotransferase (ALT).

Description

ALT will be measured by colorimetric method.

Time Frame

12 Weeks

Title

Aspartate aminotransferase (AST)

Description

AST will be measured by colorimetric method.

Time Frame

12 Weeks

Title

ɤ-glutamyltranspeptidase(GGT)

Description

ɤ-glutamyltranspeptidase(GGT) will be measured by colorimetric method.

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult (>18 years) overweight/obese subjects who have persistently abnormal aminotransferase level in two separate occasions over the past six months. NAFLD will be assumed in patients with moderately elevated aminotransferase activities (<3x the upper limit of normal). There is evidence of hepatic steatosis by imaging (increased liver echogenicity (bright), stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins) and there is no cause for secondary hepatic fat accumulation such as significant alcohol consumption, use of steatogenic medication or hereditary disorders. Patients with fibroscan score >7 kPa and <14 kPa will be included in the study. Exclusion Criteria: Alcohol abusers. Presence of evidence for viral or autoimmune hepatitis. Diabetic patients. Patients with Wilson's disease and patients with hemochromatosis. Patients with decompensated liver disease. Patients show hypersensitivity to studied medications. Patients taking medication known to cause steatosis. Patients with other comorbid conditions that could potentially elevate transaminase, such as congestive heart failure, malignancy. Pregnancy and lactating women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tarek M Mostafa, Ass. Prof.

Organizational Affiliation

Tanta University

Official's Role

Study Director

Facility Information:

Facility Name

Dr. Tarek Mohamed Mostafa

City

Tanta

State/Province

El-Gharbia

ZIP/Postal Code

31527

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27909742

Citation

Said MM, Bosland MC. The anti-inflammatory effect of montelukast, a cysteinyl leukotriene receptor-1 antagonist, against estradiol-induced nonbacterial inflammation in the rat prostate. Naunyn Schmiedebergs Arch Pharmacol. 2017 Feb;390(2):197-205. doi: 10.1007/s00210-016-1325-4. Epub 2016 Dec 1.

Results Reference

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PubMed Identifier

26989383

Citation

Kuru S, Kismet K, Barlas AM, Tuncal S, Celepli P, Surer H, Ogus E, Ertas E. The Effect of Montelukast on Liver Damage in an Experimental Obstructive Jaundice Model. Viszeralmedizin. 2015 Apr;31(2):131-8. doi: 10.1159/000375434. Epub 2015 Apr 9.

Results Reference

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

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