Non Alcoholic SteatohepatitisPhase 4NCT04537780
Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)
A Phase 4 study testing Montelukast in people with Non Alcoholic Steatohepatitis, run by Tanta University at 1 site in Egypt.
Trial summary
the current study is to evaluate the efficacy and safety of Montelukast in the treatment of patients with non-alcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Non Alcoholic Steatohepatitis
- What is being tested?
- Montelukast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2019to 30 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating the Efficacy and Safety of Montelukast in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
the current study is to evaluate the efficacy and safety of Montelukast in the treatment of patients with non-alcoholic steatohepatitis (NASH).
Read the 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
- Conditions
- Non Alcoholic Steatohepatitis
- Being tested
- Placebo, Montelukast
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo tabled every day
MontelukastDrug
Also called Singulair
Montelukast 10 mg daily at bed time.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Placebo comparator | (Control group n= 22): Patients will receive Placebo once daily at bedtime for 12 weeks.. Receives: 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. Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 8-Hydroxy2-deoxyguanisine (8-OHdG)
Quantitative detection of human 8-OHdG will be done using commercially available Enzyme-linked Immunosorbent assay kits.
Measured: 12 Weeks
TNF-α.
Quantitative detection of TNF-α will be done using commercially available Enzyme-linked Immunosorbent assay kits.
Measured: 12 Weeks
Alanine aminotransferase (ALT).
ALT will be measured by colorimetric method.
Measured: 12 Weeks
Aspartate aminotransferase (AST)
AST will be measured by colorimetric method.
Measured: 12 Weeks
ɤ-glutamyltranspeptidase(GGT)
ɤ-glutamyltranspeptidase(GGT) will be measured by colorimetric method.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start20 Aug 2019
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tarek Mohamed Mostafa, Tanta University
- Investigators
- Tarek M Mostafa, Ass. Prof., Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537780
- Sponsor's protocol ID
- Montelukast
- Status last verified
- Aug 2020
- First submitted
- 30 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27909742Kuru 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.
PubMed 26989383
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of Montelukast in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT04537780
- Acronym / sponsor ID
- Montelukast
- Conditions
- Non Alcoholic Steatohepatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| group 1 | Placebo comparator | Other: Placebo(Control group n= 22): Patients will receive Placebo once daily at bedtime for 12 weeks.. |
| Group 2 | Experimental | Drug: MontelukastTreatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime. The treatment duration will be 12 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo tabled every day | Other | group 1 |
| MontelukastAlso: SingulairMontelukast 10 mg daily at bed time. | Drug | Group 2 |
Primary outcome
serum 8-Hydroxy2-deoxyguanisine (8-OHdG)
Time frame: 12 Weeks
Quantitative detection of human 8-OHdG will be done using commercially available Enzyme-linked Immunosorbent assay kits.
TNF-α.
Time frame: 12 Weeks
Quantitative detection of TNF-α will be done using commercially available Enzyme-linked Immunosorbent assay kits.
Alanine aminotransferase (ALT).
Time frame: 12 Weeks
ALT will be measured by colorimetric method.
Aspartate aminotransferase (AST)
Time frame: 12 Weeks
AST will be measured by colorimetric method.
ɤ-glutamyltranspeptidase(GGT)
Time frame: 12 Weeks
ɤ-glutamyltranspeptidase(GGT) will be measured by colorimetric method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Background: PubMed 27909742Said 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.
- Background: PubMed 26989383Kuru 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.
- Individual participant dataSharing planned: No
Related trials for Non Alcoholic Steatohepatitis
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek M Mostafa, Ass. Prof. study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast in people with Non Alcoholic Steatohepatitis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum 8-Hydroxy2-deoxyguanisine (8-OHdG) (time frame: 12 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04537780, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.