Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-04 @ 1:51 PM
Study NCT ID:
NCT02597257
Status:
UNKNOWN
Last Update Posted:
2015-11-05
First Post:
2015-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D036881', 'term': 'Long-Term Synaptic Depression'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D009473', 'term': 'Neuronal Plasticity'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-03', 'studyFirstSubmitDate': '2015-09-18', 'studyFirstSubmitQcDate': '2015-11-03', 'lastUpdatePostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '11-point Numeric Rating Scale', 'timeFrame': '1 week after the end of intervention', 'description': 'Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain'}], 'secondaryOutcomes': [{'measure': 'Brief Pain Inventory Short Form', 'timeFrame': 'at the end of intervention and 4 weeks after the end of intervention', 'description': 'measurements of pain intensity, functionality, and impact of pain, rated on an 11-point Numerical Rating Scale (NRS) \\[0=no pain to 10=worst possible pain\\]'}, {'measure': 'Shot Form McGill Pain Questionnaire', 'timeFrame': 'at the end of intervention and 4 weeks after the end of intervention', 'description': '15 pain descriptors ranked on a 4-stage intensity scale, the Present Pain Intensity index ranked on a 6-stage intensity and VAS (100-mm scale)'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': 'at the end of intervention and 4 weeks after the end of intervention', 'description': '7-point scale from very much improved to very much worse'}, {'measure': 'Number of patients with grade 3 through grade 5 adverse events that are related to study drug, graded according to NCI CTCAE version 4.0', 'timeFrame': 'through the study completion (7 weeks)', 'description': 'AEs, laboratory values, vital signs, 12-lead ECG, finding from physical examination The intensity of AEs was graded according to the NCI common terminology criteria for adverse events v 4.0 on five point scale (grade 1 to 5: mild, moderate, severe, life-threatening and Death)'}, {'measure': '11-point Numeric Rating Scale', 'timeFrame': '4 weeks after the end of intervention', 'description': 'Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lidocaine infusion therapy'], 'conditions': ['Postherpetic Neuralgia', 'Diabetic Polyneuropathy', 'Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '29381569', 'type': 'DERIVED', 'citation': 'Kim YC, Castaneda AM, Lee CS, Jin HS, Park KS, Moon JY. Efficacy and Safety of Lidocaine Infusion Treatment for Neuropathic Pain: A Randomized, Double-Blind, and Placebo-Controlled Study. Reg Anesth Pain Med. 2018 May;43(4):415-424. doi: 10.1097/AAP.0000000000000741.'}]}, 'descriptionModule': {'briefSummary': 'The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain.', 'detailedDescription': 'The investigators expect pain improvement after treatment with 3 mg/kg of lidocaine, continuously infused in normal saline 250 ml.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postherpetic neuralgia, diabetic polyneuropathy, peripheral neuropathy\n* NRS score \\> 4\n* stable oral medication during the 1 month trial period\n* volunteers with informed consent\n\nExclusion Criteria:\n\n* pregnancy, breastfeeding, possibility of pregnancy\n* pain from causes other than upper 3 indications\n* hypersensitivity to lidocaine or other local anesthetics\n* important disease of heart, kidney, liver or incurable disease that may affect the assessment of adverse effects, or may interfere with the completion of study\n* severe conduction block\n* history of other interventions that may affect the study\n* Enrollment in other clinical trials within 30 days\n* otherwise not suitable to study'}, 'identificationModule': {'nctId': 'NCT02597257', 'briefTitle': 'Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain: Randomized, Controlled, Comparative Study', 'orgStudyIdInfo': {'id': '1720150047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': '* normal saline\n* total 250 ml\n* once a week\n* 4 times', 'interventionNames': ['Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine HCl', 'description': '* lidocaine 3 mg/kg mixed in normal saline\n* total 250 ml\n* once a week\n* 4 times', 'interventionNames': ['Drug: Lidocaine HCl']}], 'interventions': [{'name': 'Lidocaine HCl', 'type': 'DRUG', 'otherNames': ['183903BIJ, Lidocaine HCl inj. 2% DAEHAN PHARM. CO., LTD.'], 'description': 'lidocaine continuous infusion', 'armGroupLabels': ['Lidocaine HCl']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['228714BIJ, ISOTONIC SODIUM CHLORIDE DAEHAN PHARM. CO., LTD.'], 'description': 'Normal saline continuous infusion', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yong Chul Kim, PhD', 'role': 'CONTACT', 'email': 'pain@snu.ac.kr', 'phone': '+82-2-2072-3289'}, {'name': 'Jee Youn Moon, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Yong Chul Kim', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yong Chul Kim', 'role': 'CONTACT', 'email': 'pain@snu.ac.kr', 'phone': '+82-2-2072-3289'}], 'overallOfficials': [{'name': 'Yong Chul Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Food and Drug Safety, Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yong Chul Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}