Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 5:41 PM
Study NCT ID:
NCT01088594
Status:
COMPLETED
Last Update Posted:
2010-03-17
First Post:
2010-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D000077154', 'term': 'Rosiglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-16', 'studyFirstSubmitDate': '2010-02-26', 'studyFirstSubmitQcDate': '2010-03-16', 'lastUpdatePostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-course urinary sodium excretion calculated on the Day 1 of each study period', 'timeFrame': '0-6 hours'}, {'measure': 'Time-course absolute urinary sodium excretion calculated on the Day 1 of each study period', 'timeFrame': '0-6 hours'}], 'secondaryOutcomes': [{'measure': 'Sodium clearance on Day 1 of each study period', 'timeFrame': '0-6 hours'}, {'measure': 'Creatinine clearance calculated on Day 1 of each study period', 'timeFrame': '0-6 hours'}]}, 'conditionsModule': {'keywords': ['urinary sodium excretion', 'Pioglitazone', 'Rosiglitazone', 'Methodological study'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'A single centre, open, randomized, placebo controlled, 3 period cross-over study to evaluate the effects of single oral doses of pioglitazone 45mg, rosiglitazone 8mg and placebo on urinary sodium excretion in 12 healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Volunteers with Body Mass Index 18.0-28.0 kg/m2 Exclusion Criteria Clinically relevant medical history'}, 'identificationModule': {'nctId': 'NCT01088594', 'briefTitle': 'A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': 'A Methodological Study To Evaluate The Effects of Single Oral Doses Of Pioglitazone 45 mg And Rosiglitazone 8 mg On Sodium Balance In Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'S337.1.004'}, 'secondaryIdInfos': [{'id': '2009-017263-42'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'pioglitazone 45 mg', 'interventionNames': ['Drug: pioglitazone/rosiglitazone/placebo', 'Drug: rosiglitazone/pioglitazone/placebo', 'Drug: placebo/pioglitazone/rosiglitazone', 'Drug: pioglitazone/placebo/rosiglitazone', 'Drug: rosiglitazone/placebo/pioglitazone', 'Drug: placebo/rosiglitazone/pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Rosiglitazone 8 mg', 'interventionNames': ['Drug: pioglitazone/rosiglitazone/placebo', 'Drug: rosiglitazone/pioglitazone/placebo', 'Drug: placebo/pioglitazone/rosiglitazone', 'Drug: pioglitazone/placebo/rosiglitazone', 'Drug: rosiglitazone/placebo/pioglitazone', 'Drug: placebo/rosiglitazone/pioglitazone']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: pioglitazone/rosiglitazone/placebo', 'Drug: rosiglitazone/pioglitazone/placebo', 'Drug: placebo/pioglitazone/rosiglitazone', 'Drug: pioglitazone/placebo/rosiglitazone', 'Drug: rosiglitazone/placebo/pioglitazone', 'Drug: placebo/rosiglitazone/pioglitazone']}], 'interventions': [{'name': 'pioglitazone/rosiglitazone/placebo', 'type': 'DRUG', 'description': 'single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo', 'armGroupLabels': ['1', '2', '3']}, {'name': 'rosiglitazone/pioglitazone/placebo', 'type': 'DRUG', 'description': 'single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo', 'armGroupLabels': ['1', '2', '3']}, {'name': 'placebo/pioglitazone/rosiglitazone', 'type': 'DRUG', 'description': 'single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg', 'armGroupLabels': ['1', '2', '3']}, {'name': 'pioglitazone/placebo/rosiglitazone', 'type': 'DRUG', 'description': 'single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg', 'armGroupLabels': ['1', '2', '3']}, {'name': 'rosiglitazone/placebo/pioglitazone', 'type': 'DRUG', 'description': 'single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg', 'armGroupLabels': ['1', '2', '3']}, {'name': 'placebo/rosiglitazone/pioglitazone', 'type': 'DRUG', 'description': 'single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'S337.1.004 Site #', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Claire Nee', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Solvay Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}}}}