Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-28 @ 8:20 PM
Study NCT ID:
NCT05768334
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2023-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068238', 'term': 'Lubiprostone'}], 'ancestors': [{'id': 'D000527', 'term': 'Alprostadil'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).', 'timeFrame': '48 weeks', 'description': 'change in fat quantification'}], 'secondaryOutcomes': [{'measure': 'FibroScan with CAP (Controlled Attenuation Parameter)', 'timeFrame': '48 weeks', 'description': 'change in fat quantification'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NAFLD']}, 'referencesModule': {'references': [{'pmid': '39744921', 'type': 'DERIVED', 'citation': 'El-Kassas M, Mostafa H, Abdellatif W, Shoman S, Esmat G, Brahmania M, Liu H, Lee SS. Lubiprostone Reduces Fat Content on MRI-PDFF in Patients With MASLD: A 48-Week Randomised Controlled Trial. Aliment Pharmacol Ther. 2025 Feb;61(4):628-635. doi: 10.1111/apt.18478. Epub 2025 Jan 2.'}]}, 'descriptionModule': {'briefSummary': "Objectives To evaluate the efficacy, safety, and tolerability of lubiprostone in patients with nonalcoholic fatty liver disease (NAFLD).\n\nThis 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).\n\nStudy design: Randomized controlled trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- 1. Age from 18-65 years. 2. Cases with NAFLD suspected by abdominal ultrasound or CT. 3. Negative viral hepatitis markers (Hepatitis B surface Antigen \\&Hepatitis C virus Antibody).\n\n4\\. Negative autoantibodies (Antinuclear Antibody). 6. Non-cirrhotic patients as diagnosed by fibroScan (F4\\<14.6KPa). 7. Hepatic steatosis \\> 5% with MRI-PDFF.\n\nExclusion Criteria:\n\n* 1\\. History of other forms of liver disease (including viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, and alpha-1-antitrypsin disease).\n\n 2\\. Alcohol intake exceeding 30 g/day in the last 10 years or exceeding 10 g/day in the previous year (Saunders et al., 1993).\n\n 3\\. Child-Pugh score \\> 7. 4. Cirrhotic patients diagnosed by fibroScan (F4\\>14.6KPa) 5. Calculated Estimated Glomerular Filtration Rate (eGFR) \\<60 mL/min/1.73m2. 6. Pregnancy. 7. Evidence of hepatocellular carcinoma as stated by Barcelona Clinic Liver Cancer (BCLC) (Llovet et al., 2003).\n\n 8\\. Contraindications to MRI: prostetic heart valves and annuloplasty rings, metallic implants, patients who have peacemaker, and contrast allergy."}, 'identificationModule': {'nctId': 'NCT05768334', 'briefTitle': 'Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Helwan University'}, 'officialTitle': 'Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': '11-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'lubiprostone', 'description': '50 patients', 'interventionNames': ['Drug: Lubiprostone 24Mcg Oral twice daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': '50 patients', 'interventionNames': ['Drug: Lubiprostone 24Mcg Oral twice daily']}], 'interventions': [{'name': 'Lubiprostone 24Mcg Oral twice daily', 'type': 'DRUG', 'description': 'The patients will be randomized (closed envelopes) into one of two groups:\n\n1. Fifty patients will receive lubiprostone 24 mcg (microgram) twice daily.\n2. Fifty patients will receive placebo twice daily (control group). All patients will be followed for 48 weeks.', 'armGroupLabels': ['Control arm', 'lubiprostone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Hepatology and Tropical Medicine Research Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helwan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and chief of Endemic Medicine Department', 'investigatorFullName': 'Mohamed El Kassas', 'investigatorAffiliation': 'Helwan University'}}}}