Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 10:32 PM
Study NCT ID:
NCT01026961
Status:
WITHDRAWN
Last Update Posted:
2016-03-03
First Post:
2009-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D054160', 'term': 'Systolic Murmurs'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006337', 'term': 'Heart Murmurs'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010109', 'term': 'Oxymetazoline'}, {'id': 'D004115', 'term': 'Dimethindene'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study is no longer required by Brazil health authority.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-03-02', 'studyFirstSubmitDate': '2009-12-04', 'studyFirstSubmitQcDate': '2009-12-04', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing', 'timeFrame': '15 days'}, {'measure': 'To report and evaluate adverse events', 'timeFrame': '15 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'heart rate', 'systolic and diastolic blood pressure', 'arrhythmias'], 'conditions': ['Heart Rate', 'Blood Pressure', 'Arrhythmias']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://prsinfo.clinicaltrials.gov', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers between 18 and 50 years;\n* Clinical examination without abnormal findings\n* Ability to understand the nature and purpose of the study, including the risks and adverse effects\n\nExclusion Criteria:\n\n* Any cardiovascular disease, coronary artery disease, circulation problems or history of stroke, peripheral vascular disease or arrhythmia\n* History of serious adverse reactions or hypersensitivity any drug\n* Hypersensitivity to the drug study drugs or chemically related compounds'}, 'identificationModule': {'nctId': 'NCT01026961', 'briefTitle': 'Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Crossover, Double-Blind Study To Evaluate The Safety Of An Association Of Phenylephrine Hydrochloride 10mg + Acetaminophen 500mg + Dimethindene Maleate 1 Mg Compared To Phenylephrine Hydrochloride 10mg In Healthy Volunteers', 'orgStudyIdInfo': {'id': '381-A-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phenylephrine HCL/Acetaminophen/Dimethindene Maleate', 'description': 'Phenylephrine HCL/Acetaminophen/Dimethindene Maleate', 'interventionNames': ['Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phenylephrine hydrochloride', 'description': 'Phenylephrine hydrochloride 10mg', 'interventionNames': ['Drug: Phenylephrine HCL']}], 'interventions': [{'name': 'Phenylephrine HCL', 'type': 'DRUG', 'description': 'Phenylephrine HCL 10mg', 'armGroupLabels': ['Phenylephrine hydrochloride']}, {'name': 'Phenylephrine HCL/Acetaminophen/Dimethindene Maleate', 'type': 'DRUG', 'description': 'Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg', 'armGroupLabels': ['Phenylephrine HCL/Acetaminophen/Dimethindene Maleate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Scentryphar Pesquisa Clinica Ltda.', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Novartis Biociências S.A', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Biociências S.A'}}}}