Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT00058968
Status:
COMPLETED
Last Update Posted:
2007-05-17
First Post:
2003-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study for the Treatment of Painful Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Croatia', 'Germany', 'Hungary', 'Poland', 'Puerto Rico', 'Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'C564945', 'term': 'Neuropathy, Painful'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-16', 'studyFirstSubmitDate': '2003-04-15', 'studyFirstSubmitQcDate': '2003-04-15', 'lastUpdatePostDateStruct': {'date': '2007-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in average pain severity as measured by an 11-point Likert scale.'}], 'secondaryOutcomes': [{'measure': 'Pain severity for worst pain and night pain as measured by an 11-point Likert scale.'}, {'measure': 'Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment.'}, {'measure': 'Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment.'}, {'measure': 'Brief Pain Inventory to measure the severity of pain.'}, {'measure': 'Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors.'}, {'measure': 'Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy.'}, {'measure': 'Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus.'}]}, 'conditionsModule': {'keywords': ['neuropathy', 'pain', 'diabetes', 'chronic pain', 'persistent pain', 'leg pain', 'peripheral neuropathy', 'foot pain', 'painful neuropathy', 'diabetic neuropathy'], 'conditions': ['Diabetic Neuropathy, Painful']}, 'referencesModule': {'references': [{'pmid': '17327338', 'type': 'DERIVED', 'citation': 'Ziegler D, Pritchett YL, Wang F, Desaiah D, Robinson MJ, Hall JA, Chappell AS. Impact of disease characteristics on the efficacy of duloxetine in diabetic peripheral neuropathic pain. Diabetes Care. 2007 Mar;30(3):664-9. doi: 10.2337/dc06-2009.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.', 'detailedDescription': 'The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female outpatients at least 18 years of age.\n* Patients with pain due to diabetic neuropathy in both legs.\n* Females must not be pregnant or plan to become pregnant during the study.\n* Stable Glycemic control.\n* Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary.\n\nExclusion Criteria:\n\n* You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company.\n* You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis.\n* You have participated in a study for an investigational drug within the last 30 days.\n* You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders.\n* You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.'}, 'identificationModule': {'nctId': 'NCT00058968', 'briefTitle': 'A Study for the Treatment of Painful Diabetic Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy', 'orgStudyIdInfo': {'id': '4097'}, 'secondaryIdInfos': [{'id': 'F1J-MC-HMAV'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Duloxetine hydrochloride', 'type': 'DRUG'}, {'name': 'placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLilly (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}