Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01156220
Status:
WITHDRAWN
Last Update Posted:
2022-07-01
First Post:
2010-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}, {'id': 'D010130', 'term': 'p-Aminohippuric Acid'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000618', 'term': 'Aminohippuric Acids'}, {'id': 'D006626', 'term': 'Hippurates'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D007651', 'term': 'Keto Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was never implemented.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2010-07-01', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pharmacokinetic parameter of furosemide (AUC-24)', 'timeFrame': 'day 1 or day 2', 'description': 'Gender-specific comparison of the pharmacokinetic parameters of furosemide (AUC-24). The sample size calculation for this study was conducted with respect to the expected gender difference in the AUC24 of furosemide.'}, {'measure': 'pharmacodynamic parameter of furosemide (Sodium excretion in the urine)', 'timeFrame': 'day 1 or day 2', 'description': 'Gender-specific comparison of effect of furosemide on urinary excretion (sodium)'}], 'secondaryOutcomes': [{'measure': 'pharmacogenetic parameters', 'timeFrame': 'day 1', 'description': 'Influence of various genetic polymorphism (OAT1, OAT 4, OATP1B1, NKCC2, NCC, ENaC) on the variability of pharmacokinetic of furosemide'}, {'measure': 'pharmacokinetic of aminohippuric acid', 'timeFrame': 'day 1 or day 2', 'description': 'gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide'}, {'measure': 'other pharmacokinetic parameter of furosemide', 'timeFrame': 'day 1 or day 2', 'description': 'Gender-specific comparison of the other pharmacokinetic parameters of furosemide (Cmax, tmax, t½, CLoral, CLren)'}, {'measure': 'other pharmacodynamic parameter of furosemide', 'timeFrame': 'day 1 or day 2', 'description': 'Gender-specific comparison of effect of furosemide on urinary excretion (chloride, potassium, uric acid, calcium, magnesium, creatinine)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gender, diuretics, furosemide, aminohippuric acid'], 'conditions': ['Healthy Male and Female Volunteers']}, 'descriptionModule': {'briefSummary': 'In this study the gender specificity of the effects of furosemide in female and male volunteers will be investigated. The main objective is gender-specific comparison of the pharmacokinetic parameters of furosemide in relation to the effect of furosemide (urinary excretion). Secondary objectives are the gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide and the influence of various genetic polymorphisms on the variability of furosemide pharmacokinetics.', 'detailedDescription': 'In this study the gender specificity of the effects of furosemide in female and male volunteers will be investigated. The healthy volunteers receive 1. furosemide and 2. aminohippurate sodium "PAH" as single dose. The main objective is gender-specific comparison of the pharmacokinetic parameters of furosemide in relation to the effect of furosemide (urinary excretion). Secondary objectives are the gender-specific comparison of renal and systemic PAH clearance with the clearance of furosemide and the influence of various genetic polymorphisms on the variability of furosemide pharmacokinetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer for medical history and physical examination findings\n* 18 years, \\<40 years\n* Written informed consent is given\n* No clinically relevant changes in laboratory parameters\n* Inconspicuous current ECG\n* taking medication under a different drug trial within the last 30 days\n\nExclusion Criteria:\n\n* concomitant medication at study days or a week before\n* allergies or known hypersensitivity reactions to furosemide or aminohippurate sodium\n* decreased creatinine clearance by Cockcroft-Gault (\\<100 ml / min)\n* current drug abuses\n* opiate addiction within the last 10 years\n* smoking within the last year\n* pregnancy and 6 months postpartum, lactation\n* deprivation of legal capacity\n* Cooperation inability'}, 'identificationModule': {'nctId': 'NCT01156220', 'briefTitle': 'Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers', 'orgStudyIdInfo': {'id': 'IPT0901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'female', 'description': 'The healthy female volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2.', 'interventionNames': ['Drug: Furosemide', 'Drug: aminohippurate sodium']}, {'type': 'EXPERIMENTAL', 'label': 'male', 'description': 'The healthy male volunteers receive furosemide and aminohippurate sodium "PAH" as single dose randomised on day 1 or day 2', 'interventionNames': ['Drug: Furosemide', 'Drug: aminohippurate sodium']}], 'interventions': [{'name': 'Furosemide', 'type': 'DRUG', 'otherNames': ['ATC code: C03CA01', 'Product name: Lasix 40 mg Injektionslösung'], 'description': 'Injection, 40 mg, single dose over 5 min', 'armGroupLabels': ['female', 'male']}, {'name': 'aminohippurate sodium', 'type': 'DRUG', 'otherNames': ['ATC code: V04CH30,', 'Product name: Aminohipppurate Sodium "PAH"'], 'description': 'Injection, 500 mg, single dose over 5 min', 'armGroupLabels': ['female', 'male']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Clinical Trial Center North', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Thomas Eschenhagen, Prof.Dr.med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY'}, {'name': 'Ulrike Werner, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut für Experimentelle und Klinische Pharmakologie und Toxikologie Universitätsklinikum Hamburg-Eppendorf Martinistr. 52 20246 Hamburg GERMANY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}