Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-04-02 @ 11:21 AM
Study NCT ID:
NCT02100956
Status:
TERMINATED
Last Update Posted:
2023-10-03
First Post:
2014-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jimeisenach@gmail.com', 'phone': '336-716-4182', 'title': 'Professor James C. Eisenach, MD', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was terminated early due to slow recruitment and lack of funding.'}}, 'adverseEventsModule': {'timeFrame': '6 months after second intrathecal injection, up to 6.5 months', 'description': 'Peripheral oxyhemoglobin saturation, blood pressure, and heart rate were measured non invasively and recorded before and 15, 30, 60, 120, 180, 240, minutes after intrathecal injection. The electrocardiogram was continuously monitored. A neurologic examination was performed at intervals until 24 hours after injection. Serum sodium was assayed 24 hr after injection. Subjects were called 2, 3, 4, 5, 7 days, then weekly until one month and then at 6 months after the second intrathecal injection.', 'eventGroups': [{'id': 'EG000', 'title': 'Oxytocin Injection', 'description': 'Participants who received intrathecal oxytocin injection on either the first or second study day', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Injection', 'description': 'Patients who received normal saline placebo injection on either the first or second study day.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Post dural puncture headache', 'notes': 'Subject developed a post dural puncture headache after the first intrathecal injection, beginning within 24 hr and lasting 5 days. It was treated with non-prescription analgesics and resolved spontaneously', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Spontaneous Pain From Their Neuropathic Pain Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Injection', 'description': 'Participants who received intrathecal oxytocin injection on either the first or second study day'}, {'id': 'OG001', 'title': 'Placebo Injection', 'description': 'Patients who received normal saline placebo injection on either the first or second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis was that there was no difference in VAS pain scale scores after intrathecal study drug injection between oxytocin and placebo. To account for repeated measures across time and drug conditions, VAS apin scale scores were analyzed using a linear mixed-effects model with random intercepts at the level of participant. Each outcome was regressed on fixed-effects for order of study day, study drug, time after injection, and drug x time interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '240 minutes post injection', 'description': 'Pain will be measured by visual analog scale, a 10 cm line with 0/"no pain" on the left end and 10/"pain as worse as can be" on the right end. The subject places a mark on the line and the score is determined by the distance in cm from the "no pain" end.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population was defined as individuals who were randomized and received intrathecal drug on both study days of the trial. This includes subjects who completed both injections.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxytocin, Then Placebo', 'description': 'The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.\n\noxytocin 100 micrograms: oxytocin 100 micrograms administered intrathecally (IT)\n\nNormal Saline (preservative free): Normal Saline (preservative free) administered intrathecally (IT)'}, {'id': 'FG001', 'title': 'Placebo, Then Oxytocin', 'description': 'The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.\n\noxytocin 100 micrograms: oxytocin 100 micrograms administered intrathecally (IT)\n\nNormal Saline (preservative free): Normal Saline (preservative free) administered intrathecally (IT)'}], 'periods': [{'title': 'First Injection', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'At Least One Week Between Injections', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Injection', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Two subjects were not randomized, one because of an abnormal electrocardiogram and the other for lack of spontaneous neuropathic pain at rest. Six subjects were randomized and received the first intrathecal injection. Participant flow section includes randomized subjects only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxytocin, Then Placebo', 'description': 'The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.\n\noxytocin 100 micrograms: oxytocin 100 micrograms administered intrathecally (IT)\n\nNormal Saline (preservative free): Normal Saline (preservative free) administered intrathecally (IT)'}, {'id': 'BG001', 'title': 'Placebo, Then Oxytocin', 'description': 'The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.\n\noxytocin 100 micrograms: oxytocin 100 micrograms administered intrathecally (IT)\n\nNormal Saline (preservative free): Normal Saline (preservative free) administered intrathecally (IT)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '52'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '56'}, {'value': '52', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '54'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', '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': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Visual Analog Scale Pain', 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'BG000', 'lowerLimit': '3.9', 'upperLimit': '6.2'}, {'value': '2.6', 'groupId': 'BG001', 'lowerLimit': '2.3', 'upperLimit': '4.9'}, {'value': '3.9', 'groupId': 'BG002', 'lowerLimit': '2.8', 'upperLimit': '6.4'}]}]}], 'paramType': 'MEDIAN', 'description': 'The participant was asked to rate the level of their spontaneous current pain in the area of their neuropathic pain. They did so by drawing a vertical mark on a 10 cm horizontal line without gradations. Scale ranges from 0-10 with 0 meaning "No Pain" on the left end and 10 meaning "Worst Imaginable Pain" on the right end. The score is the number of cm of the mark from the left end of the horizontal line.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-18', 'size': 318112, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-07T16:41', 'hasProtocol': True}, {'date': '2022-06-20', 'size': 187485, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-04T19:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Cessation of funding period prior to completion, due to slow recruitment during the pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2014-03-27', 'resultsFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2014-03-31', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-08', 'studyFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spontaneous Pain From Their Neuropathic Pain Disease', 'timeFrame': '240 minutes post injection', 'description': 'Pain will be measured by visual analog scale, a 10 cm line with 0/"no pain" on the left end and 10/"pain as worse as can be" on the right end. The subject places a mark on the line and the score is determined by the distance in cm from the "no pain" end.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['chronic pain', 'neuropathic pain'], 'conditions': ['Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '37084261', 'type': 'DERIVED', 'citation': 'Eisenach JC, Curry RS, Houle TT. Preliminary results from a randomized, controlled, cross-over trial of intrathecal oxytocin for neuropathic pain. Pain Med. 2023 Sep 1;24(9):1058-1065. doi: 10.1093/pm/pnad051.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the effect of oxytocin given into the spinal fluid on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.', 'detailedDescription': 'Rationale: The investigators anticipate that oxytocin will be effective after spinal injection in humans to acutely relieve chronic neuropathic pain.\n\nObjectives: Determine the effect of intrathecal oxytocin on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic neuropathic pain.\n\nInterventions: A computer generated randomization will be used to determine the group for each subject. Subjects will be randomized to receive an intrathecal injection of saline (placebo) or oxytocin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Weight \\< or equal to 240 pounds\n* Neuropathic pain for \\> 6 months: with primary pain area below the umbilicus\n\nExclusion Criteria:\n\n* Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug or lidocaine\n* Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data\n* Pregnancy\n* spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment for \\> 3 months at a current dose of \\> 100 milligram (mg) morphine per day or equivalent."}, 'identificationModule': {'nctId': 'NCT02100956', 'briefTitle': 'Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain', 'orgStudyIdInfo': {'id': 'IRB00027272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin, then Placebo', 'description': 'The subject first received oxytocin 100 micrograms administered intrathecally (IT). After at least one week, they received normal saline placebo IT.', 'interventionNames': ['Drug: oxytocin 100 micrograms', 'Drug: Normal Saline (preservative free)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, then Oxytocin', 'description': 'The subject first received normal saline placebo intrathecally (IT). After at least one week, they then received oxytocin 100 micrograms administered IT.', 'interventionNames': ['Drug: oxytocin 100 micrograms', 'Drug: Normal Saline (preservative free)']}], 'interventions': [{'name': 'oxytocin 100 micrograms', 'type': 'DRUG', 'description': 'oxytocin 100 micrograms administered intrathecally (IT)', 'armGroupLabels': ['Oxytocin, then Placebo', 'Placebo, then Oxytocin']}, {'name': 'Normal Saline (preservative free)', 'type': 'DRUG', 'description': 'Normal Saline (preservative free) administered intrathecally (IT)', 'armGroupLabels': ['Oxytocin, then Placebo', 'Placebo, then Oxytocin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'James C. Eisenach, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}