Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT00841594
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2009-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011928', 'term': 'Raynaud Disease'}], 'ancestors': [{'id': 'D000090122', 'term': 'Livedoid Vasculopathy'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-13', 'studyFirstSubmitDate': '2009-02-09', 'studyFirstSubmitQcDate': '2009-02-10', 'lastUpdatePostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement and comparison of the levels of nitroglycerin and its dinitrate metabolites in the blood of healthy human volunteers after a single topical dose of MQX 503 and a single topical dose of Nitroglycerin Ointment 2%, USP.', 'timeFrame': '12 hours'}], 'secondaryOutcomes': [{'measure': 'Observation for any adverse events such as headache.', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healthy volunteers'], 'conditions': ["Raynaud's Phenomenon"]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 50 years of age\n* Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.\n* Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.\n\nExclusion Criteria:\n\n* Subjects who can not safely discontinue current prescription medications.\n* Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.\n* Subjects with an unstable medical problem.\n* Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.\n* Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.\n* Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.\n* Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.\n* Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.\n* Pregnant or nursing women.\n* Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.'}, 'identificationModule': {'nctId': 'NCT00841594', 'briefTitle': 'MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison', 'organization': {'class': 'INDUSTRY', 'fullName': 'MediQuest Therapeutics'}, 'officialTitle': 'MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects', 'orgStudyIdInfo': {'id': '08-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.\n\nApplied to the hand.', 'interventionNames': ['Drug: nitroglycerin 0.9 % (MXQ-503)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.\n\nApplied to the chest.', 'interventionNames': ['Drug: Nitroglycerin ointment 2%, USP']}], 'interventions': [{'name': 'nitroglycerin 0.9 % (MXQ-503)', 'type': 'DRUG', 'description': 'MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.', 'armGroupLabels': ['1']}, {'name': 'Nitroglycerin ointment 2%, USP', 'type': 'DRUG', 'description': 'MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98418', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Charles River Clinical Services', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MediQuest Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Fredrick Dechow, President and CEO', 'oldOrganization': 'MediQuest Therapeutics, Inc.'}}}}