Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-04 @ 5:39 PM
Study NCT ID:
NCT02363803
Status:
COMPLETED
Last Update Posted:
2019-11-15
First Post:
2015-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lidocaine for Diabetic Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sharout@wustl.edu', 'phone': '3143622628', 'title': 'Dr. Simon Haroutounian', 'organization': 'Washington University in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '0-120 minutes after infusion initiation', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Saline Infusion', 'description': 'Intravenous infusion of normal saline over a 40 minute period.\n\nPlacebo: Normal saline, approved for hypovolemia, and homeostasis.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 11, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lidocaine Infusion', 'description': 'Intravenous infusion of lidocaine \\[5mg/kg\\] over a 40 minute period.\n\nlidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 13, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Perioral numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Slurred speech', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline Infusion', 'description': 'Intravenous infusion of normal saline over a 40 minute period.\n\nPlacebo: Normal saline, approved for hypovolemia, and homeostasis.'}, {'id': 'OG001', 'title': 'Lidocaine Infusion', 'description': 'Intravenous infusion of lidocaine \\[5mg/kg\\] over a 40 minute period.\n\nlidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '46', 'groupId': 'OG000'}, {'value': '51', 'spread': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline compared to 60-120 minutes after starting the infusion', 'description': 'Spontaneous pain will be assessed on numerical rating scale NRS (0= no pain, 10=worst pain imaginable) prior to infusion and then repeatedly for 120 minutes. The outcome measure will use the average of pain intensity measured at timepoints in the 60-120 min range after beginning of infusion. The mean %change in pain (from baseline) will be compared between lidocaine and placebo arms.', 'unitOfMeasure': 'percentage of pain change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both infusions and had non-zero pain scores at the start of each infusion.'}, {'type': 'SECONDARY', 'title': 'Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline: Prior to Infusion', 'description': 'Intravenous infusion of normal saline over a 40 minute period.'}, {'id': 'OG001', 'title': 'Normal Saline: 60 Minutes After Infusion Initiation', 'description': 'Intravenous infusion of normal saline over a 40 minute period.'}, {'id': 'OG002', 'title': 'Lidocaine: Prior to Infusion', 'description': 'Intravenous infusion of lidocaine \\[5mg/kg\\] over a 40 minute period.'}, {'id': 'OG003', 'title': 'Lidocaine: 60 Minutes After Infusion Initiation', 'description': 'Intravenous infusion of lidocaine \\[5mg/kg\\] over a 40 minute period.'}], 'classes': [{'title': 'Cold intensity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Heat intensity', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3.5'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Brush intensity', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '5'}]}]}, {'title': 'Pinprick intensity', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5.5'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '- 60 minutes (baseline) and + 60 minutes of initiating infusion', 'description': 'Thermal and mechanical responses will be assessed at baseline and 60 minutes after infusions. Evoked intensities measured on a 0-10 sensory scale, where 5 is normal sensation, a number lower than 5 is reduced sensation and a number higher than 5 is greater sensation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received both lidocaine and normal saline infusions were analyzed.'}, {'type': 'SECONDARY', 'title': 'NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline: Prior to Infusion', 'description': 'Intravenous infusion of normal saline over a 40 minute period.'}, {'id': 'OG001', 'title': 'Normal Saline: 60 Minutes After Infusion Initiation', 'description': 'Intravenous infusion of normal saline over a 40 minute period.'}, {'id': 'OG002', 'title': 'Lidocaine: Prior to Infusion', 'description': 'Intravenous infusion of lidocaine \\[5mg/kg\\] over a 40 minute period.'}, {'id': 'OG003', 'title': 'Lidocaine: 60 Minutes After Infusion Initiation', 'description': 'Intravenous infusion of lidocaine \\[5mg/kg\\] over a 40 minute period.'}], 'classes': [{'title': 'Does your pain feel like burning?', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Does your pain feel like squeezing?', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Does your pain feel like electric shocks?', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '3.5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Does your pain feel like stabbing?', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4.5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Do you feel pins and needles?', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3.5'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Do you feel tingling?', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '6'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 60 minutes of initiating infusion', 'description': 'NPSI pain descriptors will be assessed prior to infusion of placebo and lidocaine (baseline) and again at 60 minutes post-infusion. Descriptors are expressed on a 0-10 scale; 0-minimum (least), and 10 maximum (worst) score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received both lidocaine and normal saline infusions analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Spontaneous Pain Intensity as a Function of Baseline MPT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline Infusion', 'description': 'Intravenous infusion of normal saline over a 40 minute period.'}, {'id': 'OG001', 'title': 'Lidocaine Infusion', 'description': 'Intravenous infusion of lidocaine \\[5mg/kg\\] over a 40 minute period.'}], 'classes': [{'categories': [{'measurements': [{'value': '.249', 'groupId': 'OG000', 'lowerLimit': '-.098', 'upperLimit': '.538'}, {'value': '.063', 'groupId': 'OG001', 'lowerLimit': '-.308', 'upperLimit': '0.404'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to 60-120 minutes after starting the infusion', 'description': 'Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.', 'unitOfMeasure': 'Pearson coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both infusions and had non-zero pain scores at the start of each infusion.'}, {'type': 'SECONDARY', 'title': 'Change in Spontaneous Pain Intensity as a Function of Baseline HPT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline Infusion', 'description': 'Intravenous infusion of normal saline over a 40 minute period.'}, {'id': 'OG001', 'title': 'Lidocaine Infusion', 'description': 'Intravenous infusion of lidocaine \\[5mg/kg\\] over a 40 minute period.'}], 'classes': [{'categories': [{'measurements': [{'value': '.023', 'groupId': 'OG000', 'lowerLimit': '-.372', 'upperLimit': '.493'}, {'value': '-.151', 'groupId': 'OG001', 'lowerLimit': '-.467', 'upperLimit': '.206'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 60-120 minutes after starting the infusion', 'description': 'Correlation between Heat Pain Threshold (HPT in degrees Celsius) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.', 'unitOfMeasure': 'Pearson coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both infusions and had non-zero pain scores at the start of each infusion. Two additional participants excluded as they could not sense heat on test site.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Saline First, Then Lidocaine', 'description': 'Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 1). Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 2)'}, {'id': 'FG001', 'title': 'Lidocaine First, Then Saline', 'description': 'Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 1). Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 2).'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'comment': 'One participant did not return for Period 2 treatment', 'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One participant only received lidocaine infusion and did not return to receive saline infusion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Saline First, Then Lidocaine', 'description': 'Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 1). Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 2)'}, {'id': 'BG001', 'title': 'Lidocaine First, Then Saline', 'description': 'Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 1). Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 2).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '12', 'groupId': 'BG000'}, {'value': '56', 'spread': '10', 'groupId': 'BG001'}, {'value': '57', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Average pain intensity within the past week', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '6.5', 'groupId': 'BG001', 'lowerLimit': '5.5', 'upperLimit': '7'}, {'value': '6.25', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '7.25'}]}]}], 'paramType': 'MEDIAN', 'description': 'Average pain within the past week at study intake, assessed on a 0-10 Numerical Rating Scale, where 0 is no pain, and 10 is worst pain imaginable', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-24', 'size': 673831, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-07T17:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2015-02-03', 'resultsFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2015-02-09', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-11', 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS)', 'timeFrame': 'Baseline compared to 60-120 minutes after starting the infusion', 'description': 'Spontaneous pain will be assessed on numerical rating scale NRS (0= no pain, 10=worst pain imaginable) prior to infusion and then repeatedly for 120 minutes. The outcome measure will use the average of pain intensity measured at timepoints in the 60-120 min range after beginning of infusion. The mean %change in pain (from baseline) will be compared between lidocaine and placebo arms.'}], 'secondaryOutcomes': [{'measure': 'Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.', 'timeFrame': '- 60 minutes (baseline) and + 60 minutes of initiating infusion', 'description': 'Thermal and mechanical responses will be assessed at baseline and 60 minutes after infusions. Evoked intensities measured on a 0-10 sensory scale, where 5 is normal sensation, a number lower than 5 is reduced sensation and a number higher than 5 is greater sensation.'}, {'measure': 'NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion', 'timeFrame': 'Baseline to 60 minutes of initiating infusion', 'description': 'NPSI pain descriptors will be assessed prior to infusion of placebo and lidocaine (baseline) and again at 60 minutes post-infusion. Descriptors are expressed on a 0-10 scale; 0-minimum (least), and 10 maximum (worst) score.'}, {'measure': 'Change in Spontaneous Pain Intensity as a Function of Baseline MPT', 'timeFrame': 'baseline to 60-120 minutes after starting the infusion', 'description': 'Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.'}, {'measure': 'Change in Spontaneous Pain Intensity as a Function of Baseline HPT', 'timeFrame': 'Baseline to 60-120 minutes after starting the infusion', 'description': 'Correlation between Heat Pain Threshold (HPT in degrees Celsius) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Peripheral Neuropathy', 'Pain']}, 'descriptionModule': {'briefSummary': 'Diabetic nerve pain \\[painful diabetic peripheral neuropathy\\] is a common medical problem with few reliably effective treatments. There is some evidence that sensory testing may help determine how individuals will respond to analgesic therapy. In this study, the investigators are evaluating the relationship between sensory testing and subject response to lidocaine infusion therapy.', 'detailedDescription': "Diabetic peripheral neuropathy \\[DPN\\] is caused by diabetes-related metabolic damage to the sensory nervous system. It affects more than 3 million Americans and is leading cause of nerve damage-associated pain worldwide. Currently approved drugs such as gabapentin, pregabalin, and duloxetine provide pain relief only in 1 out of 4 or 5 people with DPN, pointing to a great need to identify effective therapy for these patients. Recent literature suggests that certain methods of assessing sensory nerve function in neuropathic pain patients may provide prediction to individual analgesic response; however, no placebo-controlled studies have been performed with the primary goal of identifying treatment response predictors in DPN.\n\nWe propose in this study to examine whether sensory testing to determine mechanical pain threshold \\[MPT\\] or heat pain threshold \\[HPT\\] will predict the subject's response to IV lidocaine analgesic therapy. We hypothesize that people with painful DPN who have high MPT or HPT are more likely to respond to lidocaine treatment. This is a prospective, double blind, placebo-controlled study with the primary objective of determining whether the results from the sensory testing predict the response to systemic lidocaine in patients with painful DPN.\n\nConsented subjects will attend a screening visit and two intervention visits, during which they will undergo sensory testing and receive intravenous lidocaine or placebo infusion in a cross-over design. At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine the sequence of interventions: lidocaine and then placebo, or vice versa. An unblinded research nurse coordinator will be assigned to match the study number with randomized treatment sequence, and this person will prepare the study medications, which will look identical. This research nurse coordinator will not be involved at any stage at patient assessment or data analysis. The participants and all other study personnel will be blinded to the treatment allocation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18;\n2. Diagnosis of Diabetes Mellitus (Fasting Plasma Glucose \\> 126 mg/dL and/or HbA1C \\>6.5%);\n3. Distal symmetric pain in lower extremities with duration of more than 3 months;\n4. Presence of either numbness or at least 1 sensory disturbance (increased or decreased sensitivity) in the feet.\n5. Spontaneous pain with intensity of ≥ 4 on 0-10 Numerical Rating Scale (NRS).\n\nExclusion Criteria:\n\n1. Not giving consent to participate in the study;\n2. Unable to complete self-report pain questionnaire;\n3. History of moderate to severe renal or liver failure;\n4. History of other central or peripheral neurologic disorders;\n5. History of cardiac arrhythmias;\n6. Contraindication to intravenous lidocaine;\n7. Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT02363803', 'briefTitle': 'Lidocaine for Diabetic Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Predicting Individual Response to Analgesic Treatment in Painful Diabetic Neuropathy', 'orgStudyIdInfo': {'id': '201412073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline infusion then lidocaine infusion', 'description': 'Intravenous infusion of normal saline over a 40 minute period. second intervention: Intravenous infusion of lidocaine \\[5mg/kg\\] over a 40 minute period.', 'interventionNames': ['Drug: lidocaine', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine infusion, then normal saline infusion', 'description': 'Intravenous infusion of lidocaine \\[5mg/kg\\] over a 40 minute period. second intervention: Intravenous infusion of normal saline over a 40 minute period.', 'interventionNames': ['Drug: lidocaine', 'Drug: Placebo']}], 'interventions': [{'name': 'lidocaine', 'type': 'DRUG', 'description': 'lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.', 'armGroupLabels': ['Lidocaine infusion, then normal saline infusion', 'Normal saline infusion then lidocaine infusion']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Normal saline, approved for hypovolemia, and homeostasis.', 'armGroupLabels': ['Lidocaine infusion, then normal saline infusion', 'Normal saline infusion then lidocaine infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine/Barnes Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Simon Haroutounian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, WUSTL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'simon.haroutounian', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}