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

NCT04537780 | Completed Phase 4 DMC

• 1 other identifier: Montelukast
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (5)

• serum 8-Hydroxy2-deoxyguanisine (8-OHdG)

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

  12 Weeks

• TNF-α.

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

  12 Weeks

• Alanine aminotransferase (ALT).

  ALT will be measured by colorimetric method.

  12 Weeks

• Aspartate aminotransferase (AST)

  AST will be measured by colorimetric method.

  12 Weeks

• ɤ-glutamyltranspeptidase(GGT)

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

  12 Weeks

Study Arms (2)

group 1

PLACEBO COMPARATOR

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

Other: Placebo

Group 2

EXPERIMENTAL

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

Drug: Montelukast

Interventions

Placebo OTHER

Placebo tabled every day

group 1

Montelukast DRUG

Montelukast 10 mg daily at bed time.

Also known as: Singulair

Group 2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Dr. Tarek Mohamed Mostafa

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (2)

• 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.

  PMID: 27909742 BACKGROUND

• 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.

  PMID: 26989383 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

montelukast

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Tarek M Mostafa, Ass. Prof.

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 3, 2020
• Study Start: August 20, 2019
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)