Trials / Completed
CompletedNCT05768334
Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Helwan University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-11-01
- Primary completion
- 2023-02-01
- Completion
- 2023-02-01
- First posted
- 2023-03-14
- Last updated
- 2023-12-13
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT05768334. Inclusion in this directory is not an endorsement.