Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT01188733
Status:
COMPLETED
Last Update Posted:
2010-08-25
First Post:
2010-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}, {'id': 'D014648', 'term': 'Varicose Veins'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2000-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-24', 'studyFirstSubmitDate': '2010-08-23', 'studyFirstSubmitQcDate': '2010-08-24', 'lastUpdatePostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['portal hypertension', 'varices', 'cirrhosis', 'octreotide', 'somatostatin analog', 'Child Pugh Class A,B'], 'conditions': ['Cirrhosis', 'Portal Hypertension', 'Esophageal Varices']}, 'descriptionModule': {'briefSummary': 'Octreotide is used to control variceal bleeding. However, octreotide has to be given through the vein and is effective for less than two hours.\n\nIn this study the investigators determined whether a long-acting preparation of octreotide (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B.\n2. presence of small esophageal varices, defined as varices \\< 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment\n3. age ≥ 18 years\n\nExclusion Criteria:\n\n* pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control\n* allergic to sandostatin\n* high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs)\n* Child Turcotte Pugh Class C cirrhosis\n* hepatocellular carcinoma\n* evidence of ongoing alcohol or illicit drug abuse within 6 months of the study\n* serum creatinine greater than 2 mg/dL\n* platelet count below 50,000 per microliter\n* prothrombin time 4 seconds or more greater than control\n* human immunodeficiency virus (HIV) positive\n* symptomatic gallstones\n* previous history of upper gastrointestinal bleeding in the past 3 months, defined as hematemesis and/or melena\n* previous history of variceal bleeding\n* history of congestive heart failure , unstable angina, sustained ventricular tachycardia, or ventricular fibrillation\n* use of any investigational drug within 1 month prior to screening and\n* current use of beta blockers or long-acting nitrates, any other drug therapy known to have an influence on portal pressure (diuretics were allowed provided patients were on a stable dose for at least 30 days).'}, 'identificationModule': {'nctId': 'NCT01188733', 'briefTitle': 'Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis', 'orgStudyIdInfo': {'id': '10-005739'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sandostatin LAR 10mg', 'description': 'Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg', 'interventionNames': ['Drug: Long acting octreotide 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sandostatin LAR 30mg', 'description': 'Comparison of drug doses', 'interventionNames': ['Drug: Long acting Octreotide 30mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Saline control', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Long acting octreotide 10mg', 'type': 'DRUG', 'otherNames': ['Long-acting octreotide'], 'description': 'Comparison of different doses', 'armGroupLabels': ['Sandostatin LAR 10mg']}, {'name': 'Long acting Octreotide 30mg', 'type': 'DRUG', 'description': 'Comparison of drug doses', 'armGroupLabels': ['Sandostatin LAR 30mg']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Comparison of drug doses', 'armGroupLabels': ['Saline']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Patrick S. Kamath', 'oldOrganization': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester MN 55905'}}}}