Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 12:20 AM
Study NCT ID:
NCT00737594
Status:
TERMINATED
Last Update Posted:
2019-11-18
First Post:
2008-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581134', 'term': 'cobiprostone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@mnk.com', 'phone': '800-556-3314', 'title': 'Medical Information Call Center', 'phoneExt': '5', 'organization': 'Mallinckrodt Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial terminated before data were collected.'}}, 'adverseEventsModule': {'timeFrame': 'The trial terminated before data were collected', 'description': 'The trial terminated before data were collected', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo: 0 mcg capsules three times daily (TID)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '12 mcg TID', 'description': 'Cobiprostone 36 mcg\n\nCobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '18 mcg TID', 'description': 'Cobiprostone 54 mcg\n\nCobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: 0 mcg capsules three times daily (TID)'}, {'id': 'OG001', 'title': '12 mcg TID', 'description': 'Cobiprostone 36 mcg\n\nCobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)'}, {'id': 'OG002', 'title': '18 mcg TID', 'description': 'Cobiprostone 54 mcg\n\nCobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)'}], 'timeFrame': '4 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated early, data were not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo: 0 mcg capsules three times daily (TID)'}, {'id': 'FG001', 'title': '12 mcg TID', 'description': 'Cobiprostone 36 mcg\n\nCobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)'}, {'id': 'FG002', 'title': '18 mcg TID', 'description': 'Cobiprostone 54 mcg\n\nCobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '9 participants were recruited, but the study terminated before data were collected'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo: 0 mcg capsules three times daily (TID)'}, {'id': 'BG001', 'title': '12 mcg TID', 'description': 'Cobiprostone 36 mcg\n\nCobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)'}, {'id': 'BG002', 'title': '18 mcg TID', 'description': 'Cobiprostone 54 mcg\n\nCobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'The study terminated before data were collected'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Failure to enroll a suitable number of qualified subjects.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-31', 'studyFirstSubmitDate': '2008-08-15', 'resultsFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2008-08-15', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-16', 'studyFirstPostDateStruct': {'date': '2008-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Portal Hypertension']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is \\>= 18 years of age.\n* Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.\n* Patient has clinical diagnosis of cirrhosis.\n* Patient has undergone variceal banding.\n\nExclusion Criteria:\n\n* Patient has a Child-Pugh score \\>12.\n* Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.\n* Variceal banding procedure was performed within 1 month of the screening visit.\n* Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.\n* Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.\n* Patient has hepatocellular carcinoma that is being medically treated or is advanced.\n* Patient has impaired renal function (i.e., serum creatinine concentration \\>1.8 mg/dl)\n* Patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.\n* Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.'}, 'identificationModule': {'nctId': 'NCT00737594', 'briefTitle': 'Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension', 'orgStudyIdInfo': {'id': 'SPH0721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo TID', 'description': 'Participants receive matching placebo capsules three times daily (TID)', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '12 mcg TID', 'description': 'Participants receive 12 mcg Cobiprostone TID', 'interventionNames': ['Drug: Cobiprostone']}, {'type': 'EXPERIMENTAL', 'label': '18 mcg TID', 'description': 'Participants receive 18 mcg Cobiprostone TID', 'interventionNames': ['Drug: Cobiprostone']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Matching placebo'], 'description': 'Matching placebo capsules for oral administration', 'armGroupLabels': ['Placebo TID']}, {'name': 'Cobiprostone', 'type': 'DRUG', 'otherNames': ['Experimental product'], 'description': 'Cobiprostone capsules for oral administration', 'armGroupLabels': ['12 mcg TID', '18 mcg TID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sucampo Pharma Americas, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sucampo Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}