Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT01996605
Status:
TERMINATED
Last Update Posted:
2023-09-14
First Post:
2013-11-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Spinal Oxytocin in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': 'The study was powered for a sample size of 40 and was terminated early with a sample size of 20 due to slow recruitment and cessation of financial support.'}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Oxytocin 15 mcg', 'description': 'Oxytocin 15 mcg injected spinally\n\nOxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oxytocin 150 mcg', 'description': 'Oxytocin 150 mcg injected spinally\n\nOxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Preservative free normal saline injected spinally\n\nPlacebo: placebo will be administered spinally', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hyperalgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin 15 mcg', 'description': 'Oxytocin 15 mcg injected spinally\n\nOxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally'}, {'id': 'OG001', 'title': 'Oxytocin 150 mcg', 'description': 'Oxytocin 150 mcg injected spinally\n\nOxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Preservative free normal saline injected spinally\n\nPlacebo: placebo will be administered spinally'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'spread': '55', 'groupId': 'OG000'}, {'value': '102', 'spread': '76', 'groupId': 'OG001'}, {'value': '75', 'spread': '33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'T', 'groupDescription': 'The null hypothesis was that there would be no difference in area of hyperalgesia 105 minutes after study drug injection among the three groups.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'A one-way ANOVA was performed on the single primary outcome datapoint comparing the three groups.'}], 'paramType': 'MEAN', 'timeFrame': '105 minutes after study drug injection', 'description': 'The area of hyperalgesia after the first skin heating following topical capsaicin.', 'unitOfMeasure': 'square centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Area of hyperalgesia was determined as described in baseline measures 105 min after study drug injection. The sequence of events was study drug injection followed in 30 min by 5 min heating of the skin followed by capsaicin cream application for 30 min, removal of the cream followed in 30 min by 5 min heating of the skin. After this second heating the area of hyperalgesia was measured.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxytocin 15 mcg', 'description': 'Oxytocin 15 mcg injected spinally\n\nOxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally'}, {'id': 'FG001', 'title': 'Oxytocin 150 mcg', 'description': 'Oxytocin 150 mcg injected spinally\n\nOxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Preservative free normal saline injected spinally\n\nPlacebo: placebo will be administered spinally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from Jan 2, 2014 to Oct 9, 2018 within Wake Forest University Health Sciences (WFUHS) and the community using IRB-approved advertisements. Screening for eligibility and informed consent was obtained at the Pain Mechanisms Laboratory Clinical Research Unit of WFUHS.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxytocin 15 mcg', 'description': 'Oxytocin 15 mcg injected spinally\n\nOxytocin 15 mcg: Oxytocin 15 mcg will be administered spinally'}, {'id': 'BG001', 'title': 'Oxytocin 150 mcg', 'description': 'Oxytocin 150 mcg injected spinally\n\nOxytocin 150 mcg: Oxytocin 150 mcg will be administered spinally'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Preservative free normal saline injected spinally\n\nPlacebo: placebo will be administered spinally'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '11', 'groupId': 'BG000'}, {'value': '35', 'spread': '9', 'groupId': 'BG001'}, {'value': '38', 'spread': '10', 'groupId': 'BG002'}, {'value': '36', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Area of hyperalgesia', 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000'}, {'value': '0', 'spread': '0', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '0', 'spread': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Area of hyperalgesia was determined by applying a von Frey filament to the skin with normal sensation and sequentially approaching the site of capsaicin application along a radial line until the participant indicated the sensation changed from normal to a prick or pain sensation. This point was marked and the area determined.\n\nNOTE: At baseline prior to capsaicin application there was no hyperalgesia, so all values are 0.', 'unitOfMeasure': 'square centimeters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-25', 'size': 303905, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-02T13:55', 'hasProtocol': True}, {'date': '2022-01-25', 'size': 198109, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-04T19:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization is prepared by a statistician not otherwise involved in the study or data analysis and is maintained by the Wake Forest University School of Medicine research pharmacy. Study drug is dispensed by the research pharmacy labelled as "Study drug containing normal saline or oxytocin 15 mcg in normal saline or oxytocin 150 mcg in normal saline" to indicate the possible contents of the solution, thereby maintaining blind.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects are randomized into one of 3 groups to receive, in a double-blind manner, intrathecal saline or intrathecal oxytocin, 15 mcg or 150 mcg'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Cessation of funding period prior to completion, due to slow recruitment during the pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2013-11-21', 'resultsFirstSubmitDate': '2023-08-07', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-31', 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperalgesia', 'timeFrame': '105 minutes after study drug injection', 'description': 'The area of hyperalgesia after the first skin heating following topical capsaicin.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer Study']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.', 'detailedDescription': 'Purpose: There is a strong experimental basis to support the study of oxytocin by the spinal route for analgesia in humans. Oxytocin containing cells in the dorsal parvocellular division of the paraventricular nucleus (PVN) project to the spinal cord (1). Noxious stimulation activates these cells via the A1 noradrenergic relay in the pons (2) and produces analgesia by spinal release of oxytocin, since intrathecal injection of an oxytocin receptor antagonist worsens pain behaviors from peripheral inflammation (3). Direct electrical stimulation of the PVN reduces dorsal horn neuronal responses to noxious stimulation, and this is blocked by administration of sequestering antibody for oxytocin (4). Similarly, direct electrical stimulation of the PVN reduces behavioral sensitivity in a model of chronic neuropathic pain, and this effect is blocked by an oxytocin receptor antagonist (5). Intrathecal injection of oxytocin in normal rats reduces dorsal horn neuronal responses to noxious stimuli (6) as well as behavioral responses to noxious thermal (3), mechanical (3), and chemical (7) stimuli. Finally, intrathecal injection of oxytocin in rat models of chronic pain also reduces dorsal horn neuronal responses to sensory stimulation (6) as well as behavioral responses to thermal (5) and mechanical (7) stimuli.\n\nRationale: We anticipate that oxytocin will be effective after spinal injection in humans against chemical induced hypersensitivity states.\n\nObjectives: Determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy\n* weight \\< 240 pounds\n* American Society of Anesthesiology Category 1 or 2\n\nExclusion Criteria:\n\n* allergy to oxytocin or lidocaine\n* allergy to chilli peppers\n* Females: active gynecological disease such as uterine fibroids or ongoing bleeding\n* Pregnancy or currently breastfeeding\n* Females that have delivered a baby within 2 years of study\n* Taking prescription medications (exception: oral birth control medication)'}, 'identificationModule': {'nctId': 'NCT01996605', 'briefTitle': 'Efficacy of Spinal Oxytocin in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Efficacy of Intrathecal Oxytocin in Human Volunteers', 'orgStudyIdInfo': {'id': 'IRB00025901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin 15 mcg', 'description': 'Oxytocin 15 mcg injected spinally', 'interventionNames': ['Drug: Oxytocin 15 mcg']}, {'type': 'EXPERIMENTAL', 'label': 'Oxytocin 150 mcg', 'description': 'Oxytocin 150 mcg injected spinally', 'interventionNames': ['Drug: Oxytocin 150 mcg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Preservative free normal saline injected spinally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oxytocin 15 mcg', 'type': 'DRUG', 'description': 'Oxytocin 15 mcg will be administered spinally', 'armGroupLabels': ['Oxytocin 15 mcg']}, {'name': 'Oxytocin 150 mcg', 'type': 'DRUG', 'description': 'Oxytocin 150 mcg will be administered spinally', 'armGroupLabels': ['Oxytocin 150 mcg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo will be administered spinally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'James C Eisenach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}