Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-23 @ 8:02 AM
Study NCT ID:
NCT00113620
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2005-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2005-06-09', 'studyFirstSubmitQcDate': '2005-06-09', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain rating scale obtained from patient diaries'}], 'secondaryOutcomes': [{'measure': 'Additional diary rating scales and scores obtained from clinic visits'}]}, 'conditionsModule': {'keywords': ['distal symmetrical', 'pain', 'lower extremities', 'dextromethorphan'], 'conditions': ['Pain', 'Diabetic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '22314263', 'type': 'RESULT', 'citation': 'Shaibani AI, Pope LE, Thisted R, Hepner A. Efficacy and safety of dextromethorphan/quinidine at two dosage levels for diabetic neuropathic pain: a double-blind, placebo-controlled, multicenter study. Pain Med. 2012 Feb;13(2):243-54. doi: 10.1111/j.1526-4637.2011.01316.x. Epub 2012 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus\n* Established diabetic therapy for at least 3 months\n* Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy\n* Pain the previous three months\n* Not pregnant\n\nExclusion Criteria:\n\n* Patient failed adequate trial of 3 or more medications or has required narcotics for pain\n* History of torsades de pointes\n* Sensitivity to quinidine or opiate drugs (codeine, etc)\n* Severe pain that could confound the assessment\n* Patient has had any amputations\n* Patient has participated in the past 30 days or is currently participating in another trial\n* Patient has previously received treatment with dextromethorphan and quinidine'}, 'identificationModule': {'nctId': 'NCT00113620', 'briefTitle': 'Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avanir Pharmaceuticals'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dextromethorphan and Quinidine at Two Dose Levels in the Treatment of the Pain of Diabetic Neuropathy', 'orgStudyIdInfo': {'id': '04-AVR-109'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neurodex', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pivotal Research Centers', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dedicate Clinical Research, Inc.', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Central Arkansas Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Solutions', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '94546', 'city': 'Castro Valley', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Foot Care', 'geoPoint': {'lat': 37.6941, 'lon': -122.08635}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'South Bay Clinical Research Inc.', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Sleep Medicine Services, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Sleep Medicine Services, Inc.', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '95831', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Research Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Bay Medical Research', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'University Clinical Research - DeLand', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'The Center for Diabetes and Endocrine Care', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'FPA Clinical Research', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Neuroscience Associates, Inc.', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33351', 'city': 'Sunrise', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Clinical Research, Inc.', 'geoPoint': {'lat': 26.13397, 'lon': -80.1131}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Laszlo J. 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