Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT01510860
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2012-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-03', 'studyFirstSubmitDate': '2012-01-12', 'studyFirstSubmitQcDate': '2012-01-17', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of liver enzymes between baseline and the end of the treatment-period with Ursofalk 250 mg capsules and the end of treatment-period with Ursofalk 500 mg tablets.', 'timeFrame': 'Between baseline and week 24'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'Between baseline and week 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Biliary Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '27121784', 'type': 'RESULT', 'citation': 'Hopf C, Grieshaber R, Hartmann H, Hinrichsen H, Eisold M, Cordes HJ, Greinwald R, Rust C. Therapeutic Equivalence of Ursodeoxycholic Acid Tablets and Ursodeoxycholic Acid Capsules for the Treatment of Primary Biliary Cirrhosis. Clin Pharmacol Drug Dev. 2013 Jul;2(3):231-6. doi: 10.1002/cpdd.24. Epub 2013 Apr 15. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Negative pregnancy\n* Signed informed consent\n* Histologically proven non-cirrhotic liver disease\n\nExclusion Criteria:\n\n* histologically proven cirrhosis\n* PBC stage II+IV\n* Positive HIV serology'}, 'identificationModule': {'nctId': 'NCT01510860', 'briefTitle': 'Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dr. Falk Pharma GmbH'}, 'officialTitle': 'Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary Cirrhosis', 'orgStudyIdInfo': {'id': 'URT-15/PBC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ursodeoxycholic acid (UDCA)250 mg', 'description': 'UDCA 250 mg capsule', 'interventionNames': ['Drug: UDCA (Ursodeoxycholic acid)']}, {'type': 'EXPERIMENTAL', 'label': 'Ursodeoxycholic acid (UDCA)500 mg', 'description': 'UDCA 500 mg tablet', 'interventionNames': ['Drug: UDCA (Ursodeoxycholic acid)']}], 'interventions': [{'name': 'UDCA (Ursodeoxycholic acid)', 'type': 'DRUG', 'description': '250 mg', 'armGroupLabels': ['Ursodeoxycholic acid (UDCA)250 mg']}, {'name': 'UDCA (Ursodeoxycholic acid)', 'type': 'DRUG', 'description': '500 mg', 'armGroupLabels': ['Ursodeoxycholic acid (UDCA)500 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum Grosshadern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Christian Rust, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Grosshadern Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Falk Pharma GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}