MedTrace Logo

Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease

NCT05768334 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2023-12-13

No results posted yet for this study

Summary

Objectives To evaluate the efficacy, safety, and tolerability of lubiprostone in patients with nonalcoholic fatty liver disease (NAFLD).

This study will include 100 patients with nonalcoholic fatty liver disease (NAFLD) recruited from the specialized NAFLD outpatient's clinic in National Hepatology and Tropical Medicine Research Institute (NHTMRI).

Study design: Randomized controlled trial.

Conditions

  • NAFLD

Interventions

DRUG

Lubiprostone 24Mcg Oral twice daily

The patients will be randomized (closed envelopes) into one of two groups: 1. Fifty patients will receive lubiprostone 24 mcg (microgram) twice daily. 2. Fifty patients will receive placebo twice daily (control group). All patients will be followed for 48 weeks.

Sponsors & Collaborators

  • Helwan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05768334 on ClinicalTrials.gov