Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
Study NCT ID:
NCT01218568
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2010-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006501', 'term': 'Hepatic Encephalopathy'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}, {'id': 'D007792', 'term': 'Lactulose'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-02', 'studyFirstSubmitDate': '2010-10-05', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reversal of hepatic encephalopathy', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '10 days'}, {'measure': 'duration of hospital stay', 'timeFrame': '10 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatic Encephalopathy']}, 'descriptionModule': {'briefSummary': 'The study will be double blind with respect to rifaximin, and randomization will be performed using tables of computer-generated random numbers. All subjects will be followed up till the recovery of HE (primary end point) or 10 days whichever is earlier. In the Lactulose group (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day along with placebo . In the lactulose plus rifaximin group (group B) patients will receive cap rifaximin 400mg three times a day along with lactulose. Primary endpoints will be recovery of overt HE patients who will not recover from HE after 10 days will be continued on the same treatment. Total duration of the study is 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhosis\n* Age 18-80\n* Hepatic encephalopathy grade II-IV\n* Informed consent\n\nExclusion Criteria:\n\n1. Degenerative CNS disease or major psychiatric illness\n2. Serum creatinine \\> 1.5 mg/dl\n3. Active alcohol intake \\<4 weeks prior to present episode\n4. Others metabolic encephalopathies\n5. Hepatocellular Carcinoma\n6. Severe comorbidity such as CHF, Pulmonary disease, Neurological \\& Psychiatric problems impairing quality of life'}, 'identificationModule': {'nctId': 'NCT01218568', 'briefTitle': 'Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial', 'orgStudyIdInfo': {'id': 'ILBS HE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rifaximin plus lactulose', 'interventionNames': ['Drug: Rifaximin plus lactulose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lactulose', 'description': '30-60ml/day', 'interventionNames': ['Drug: Lactulose']}], 'interventions': [{'name': 'Rifaximin plus lactulose', 'type': 'DRUG', 'description': 'Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.', 'armGroupLabels': ['Rifaximin plus lactulose']}, {'name': 'Lactulose', 'type': 'DRUG', 'description': 'Lactulose 30-60 ml in two or three divided doses.', 'armGroupLabels': ['lactulose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110 070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Institute of Liver & Biliary Sciences (ILBS)', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}