Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-02 @ 9:52 AM
Study NCT ID:
NCT01533766
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2012-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety, Efficacy Study of CombiflexOmega Versus SmofKabiven in Patients With Parenteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-15', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-02-10', 'lastUpdatePostDateStruct': {'date': '2013-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of adverse drug reaction', 'timeFrame': '6days'}], 'secondaryOutcomes': [{'measure': 'Changes of laboratory parameters (biochemistry, hematology, coagulation)', 'timeFrame': '7days'}, {'measure': 'Changes of vital signs', 'timeFrame': '7days'}]}, 'conditionsModule': {'conditions': ['Parent']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy of CombiflexOmega in comparison to SmofKabiven in postoperative patients requiring parenteral nutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 20 and older\n* Patients are expected to require PN for more than 5 days\n* Patients who voluntarily signed the consent form\n\nExclusion Criteria:\n\n* Patients are expected difficult to survive more than 5 days\n* Pregnant or breast-feeding women\n* BMI \\> 30 kg/m2\n* Patients with severe blood coagulation disorders\n* Patients with congenital amino acid metabolism disorders\n* Patients with acute shock\n* Patients with uncontrollable diabetes mellitus\n* Patients with hemophage syndrome\n* Patients with hypopotassemia (K \\< 3.0mEq/L)\n* Patients having the history of myocardial infarction\n* Patients reported the following laboratory value\n\n * fasting TG \\> 250mg/dl, TC \\> 300mg/dl\n * ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas)\n * Creatinine ≥ 1.5mg/dl\n * Ca \\> 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L\n* Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug\n* Patients having the history of drug or alcohol abuse\n* General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, cardiac decompensation\n* Patients are in unstable conditions\n* Patients with difficult peripheral intravenous\n* Patients with parenteral nutrition within 7 days prior to start of the trial\n* Participation in another clinical study with an investigational drug or an investigational medical device within 28 days prior to start of study\n* Patients judged to be unsuitable for this trial by investigators'}, 'identificationModule': {'nctId': 'NCT01533766', 'acronym': 'OMEGA', 'briefTitle': 'A Safety, Efficacy Study of CombiflexOmega Versus SmofKabiven in Patients With Parenteral Nutrition', 'organization': {'class': 'INDUSTRY', 'fullName': 'JW Pharmaceutical'}, 'officialTitle': 'A Randomized, Open, Multicenter, Compared Phase III Trial to Evaluate the Safety, Efficacy of CombiflexOmega and SmofKabiven in Postoperative Patients Requiring Parenteral Nutrition', 'orgStudyIdInfo': {'id': 'CW-CFO-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CombiflexOmega', 'interventionNames': ['Drug: CombiflexOmega']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SmofKabiven', 'interventionNames': ['Drug: SmofKabiven']}], 'interventions': [{'name': 'CombiflexOmega', 'type': 'DRUG', 'description': 'intravenously over 5 days infusion', 'armGroupLabels': ['CombiflexOmega']}, {'name': 'SmofKabiven', 'type': 'DRUG', 'description': 'intravenously over 5 days infusion', 'armGroupLabels': ['SmofKabiven']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JW Life Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}