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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06302049
Other study ID # 12345
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 1, 2024
Est. completion date May 1, 2026

Study information

Verified date May 2024
Source Sadat City University
Contact aya hesham eltabbakh, bachelor
Phone +201094393402
Email aya.eltabaakh@fop.usc.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.


Recruitment information / eligibility

Status Recruiting
Enrollment 46
Est. completion date May 1, 2026
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: Both males and females. - Diabetic and non-diabetic patients. - Age >18 years old. - Overweight and obese patient: Body mass index (BMI) = 25 kg/ m2 but <40 kg/ m2. - Patients with heartburn, peptic ulcer, gastrointestinal reflux disease, erosive esophagitis, Zollinger-Ellison syndrome and helicobacter pylori infection. - Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (>2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, HAIR score of 2 or 3. Exclusion Criteria: - Patients with a history of hypersensitivity to esomeprazole. - Patients with BMI = 40 kg/ m2. - Patients taking warfarin, clopidogrel, digoxin, diazepam and phenytoin to avoid drug-drug interactions as these drugs are CYP2C19 substrates. - Patients infected with human immune deficiency virus taking antiretroviral medicines or dosage forms containing rilpivirine. - Patients with a history of viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, biliary obstruction, primary biliary cirrhosis, hemochromatosis, Wilson's disease and alpha-1 antitrypsin deficiency. - Patients on medications associated with steatosis such as NSAIDs, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate. - Patients with cancer or with a history of cancer. - Patients with cardiovascular diseases. - Pregnant and lactating females

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Esomeprazole
esomeprazole 20 mg once daily
Placebo
Placebo once daily

Locations

Country Name City State
Egypt National Liver Institute Shibin Al Kawm

Sponsors (1)

Lead Sponsor Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS) Increase in NAFLD fibrosis score indicates high probability of advanced liver fibrosis Score lower than -1.5 indicates low probability of advanced liver fibrosis (F0-F2).
Score higher than or equals -1.5 to < 0.67 indicates intermediate probability of advanced liver fibrosis.
Score higher than or equals 0.67 indicates high probability of advanced liver fibrosis (F3-F4)
Before and after 3 months of the intervention
Secondary Liver function improvement change in the other measured parameters such as liver panel Before and after 3 months of the intervention
Secondary Reduction of oxidative stress Decrease in the serum level of malondialdehyde (MDA) Before and after 3 months of the intervention
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