Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT00568035
Status:
COMPLETED
Last Update Posted:
2009-01-08
First Post:
2007-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-07', 'studyFirstSubmitDate': '2007-12-03', 'studyFirstSubmitQcDate': '2007-12-03', 'lastUpdatePostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the safety of a three times daily application of QR-333 as compared to placebo.', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Determine the efficacy of QR-333 on symptoms of diabetic neuropathy and the impact of QR-333 on the daily activities (including pain and sleep disturbance) of subjects with symptomatic diabetic neuropathy as compared to placebo.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetic', 'peripheral', 'neuropathy'], 'conditions': ['Diabetic Neuropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether QR-333 is safe and effective in the treatment of diabetic neuropathy as compared to placebo.', 'detailedDescription': 'Diabetic neuropathy is among the most common complication of diabetes, resulting in pain and numbness, which affects the patients sleep, functioning and well-being. The pain is often accompanied by unpleasant sensations described as buzzing, cramp-like, burning, or jolting. The pain is usually symmetrical and occurs in the upper and lower extremities following a "glove and stocking" distribution.\n\nTo date there is no fully effective treatment for diabetic neuropathy. Therapy is tailored individually according to subject complaints and may be selected from categories including Non-steroidal anti-inflammatory drugs (NSAIDs) and adjuvant analgesics (including tricyclic antidepressants and anticonvulsants).\n\nThe clinical trial is being conducted to determine the safety and efficacy of QR-333 in the treatment of diabetic neuropathy as compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of diabetic neuropathy\n* must have some pain daily in the lower limbs due to diabetic polyneuropathy for at least 3 months prior to enrollment\n* must be willing to comply with study directions, write information in a diary (such as pain medications taken), read and comprehend written instructions, complete questionnaires, and have the ability to apply the cream as directed\n\nExclusion Criteria:\n\n* uncontrolled pain that has persisted for \\> 12 months.'}, 'identificationModule': {'nctId': 'NCT00568035', 'briefTitle': "Safety and Efficacy Study of QR-333 in Patient's With Symptomatic Diabetic Neuropathy", 'organization': {'class': 'INDUSTRY', 'fullName': 'Quigley Pharma, Inc.'}, 'officialTitle': 'Phase II Study of QR-333 for the Treatment of Symptomatic Diabetic Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'QR-333-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'QR-333', 'interventionNames': ['Drug: QR-333']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: QR-333']}], 'interventions': [{'name': 'QR-333', 'type': 'DRUG', 'description': 'QR-333 or placebo will be applied three times a day for 12 weeks', 'armGroupLabels': ['Placebo', 'QR-333']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Parkway Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Seale Harris Clinic / Alliance Clinical Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Sleep Medicine Services, Inc', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90712', 'city': 'Lakewood', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Medical Research, LLC', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '35201', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Clinical Research', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Stedman Clinical Trails', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Metabolic Research Institute, Inc.', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'A&A Pain Institute', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rwjms/Umdnj', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07006', 'city': 'West Caldwell', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Land Clinical Studies', 'geoPoint': {'lat': 40.84852, 'lon': -74.29695}}, {'zip': '14209', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Kaleida Health, Diabetes Center of WNY', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'ECU Diabetes Research Center, Brody School of Medicine', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Hartwell Research Group / Anderson Family Care', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'dgd Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials, PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center, Inc', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'Philip Raskin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Texas, Southwestern Medical Center at Dallas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quigley Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Quigley Pharma, Inc.', 'oldOrganization': 'Richard Rosenbloom'}}}}