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Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis

S

Sadat City University

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Steatohepatitis, Nonalcoholic
Fatty Liver Disease

Treatments

Drug: Esomeprazole
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

46 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups, including a placebo group

esomeprazole group
Experimental group
Description:
patients in this arm will receive esomeprazole 20 mg once daily
Treatment:
Drug: Esomeprazole
Placebo group
Placebo Comparator group
Description:
patients in this arm will receive placebo once daily
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

aya hesham eltabbakh, bachelor

Data sourced from clinicaltrials.gov

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