Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT00266669
Status:
COMPLETED
Last Update Posted:
2007-08-08
First Post:
2005-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011928', 'term': 'Raynaud Disease'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], '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'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2006-05'}, 'lastUpdateSubmitDate': '2007-08-06', 'studyFirstSubmitDate': '2005-12-15', 'studyFirstSubmitQcDate': '2005-12-15', 'lastUpdatePostDateStruct': {'date': '2007-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Improvements in Raynaud's Assessment Score comparing active to placebo"}, {'measure': "Reduction of number of Raynaud's events"}, {'measure': "Decrease in duration of Raynaud's events"}, {'measure': "Decrease in symptoms associated with Raynaud's"}, {'measure': 'Assess safety: frequency and severity of adverse events associated with the study drug'}], 'secondaryOutcomes': [{'measure': "Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions"}, {'measure': 'Reduction in emergence of digital ulcers for patients with scleroderma'}]}, 'conditionsModule': {'keywords': ["Raynaud's Phenomenon", "Raynaud's Disease", 'Scleroderma', "Raynaud's Disease Secondary to Scleroderma", "Raynaud's Disease Secondary to Other Autoimmune Disease"], 'conditions': ["Raynaud's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Raynaud's phenomenon\n* 2 or more Raynaud's events on a typical winter day\n* Agree to discontinue current treatments for Raynaud's\n* Negative pregnancy test and agree to use effective contraception during study\n\nExclusion Criteria:\n\n* Current use of nitrate medications or medications known to interact with nitroglycerin\n* Patients who currently use medications, like calcium channel blockers, that might interfere with study medication\n* Patients with a known allergy to nitroglycerin or common topical ingredients\n* Patients with a history of migraine headaches\n* Patients with a history of unstable medical problems\n* Patients with cognitive or language difficulties that would impair completion of assessment instruments\n* Patients with lab screening values more than 20% outside normal range\n* Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening\n* Pregnant or nursing women\n* Women of child-bearing potential who are unwilling to comply with the contraceptive requirements"}, 'identificationModule': {'nctId': 'NCT00266669', 'briefTitle': "Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon", 'organization': {'class': 'INDUSTRY', 'fullName': 'MediQuest Therapeutics'}, 'officialTitle': 'Phase III "in-Life" Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud\'s Phenomenon', 'orgStudyIdInfo': {'id': '05-002'}, 'secondaryIdInfos': [{'id': 'MQX-503 In-Life'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Topical organogel with nitroglycerin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Medical School', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado at Denver and Health Sciences Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Center for Advanced Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University School of Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arthritis Education & Treatment Center, PLLC', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University of Medicine and Dentistry of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'The Center for Rheumatology', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11733', 'city': 'East Setauket', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Stony Brook', 'geoPoint': {'lat': 40.94149, 'lon': -73.10594}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medical University of Ohio', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical School at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Benaroya Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Health Care", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'SMBD Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MediQuest Therapeutics', 'class': 'INDUSTRY'}}}}