Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-26 @ 12:46 PM
Study NCT ID:
NCT00414466
Status:
TERMINATED
Last Update Posted:
2013-08-23
First Post:
2006-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.j.spencer@medtronic.com', 'phone': '(763) 514-0253', 'title': 'Robert Spencer, Clinical Research Manager', 'organization': 'Medtronic Neuromodulation'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are reported through 29 days post-randomization, including 22 days of dosing at the randomized dose and 7 days of dose reduction.', 'description': 'All randomized subjects were included in adverse event summaries.', 'eventGroups': [{'id': 'EG000', 'title': '1 Placebo', 'description': 'Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system', 'otherNumAtRisk': 44, 'otherNumAffected': 30, 'seriousNumAtRisk': 44, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '2 Gabapentin Low', 'description': 'Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose', 'otherNumAtRisk': 42, 'otherNumAffected': 21, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '3 Gabapentin Medium', 'description': 'Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose', 'otherNumAtRisk': 41, 'otherNumAffected': 27, 'seriousNumAtRisk': 41, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': '4 Gabapentin High', 'description': 'Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose', 'otherNumAtRisk': 43, 'otherNumAffected': 25, 'seriousNumAtRisk': 43, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Implant site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'seriousEvents': [{'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Implant site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Bone marrow disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Neuropathic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Oesophageal spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Closed head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Therapeutic agent toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 Placebo', 'description': 'Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system'}, {'id': 'OG001', 'title': '2 Gabapentin Low', 'description': 'Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'OG002', 'title': '3 Gabapentin Medium', 'description': 'Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'OG003', 'title': '4 Gabapentin High', 'description': 'Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.99', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '1.11', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.802', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05, two-sided.', 'groupDescription': "Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.", 'statisticalMethod': 'Williams test for minimum effective dose', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.874', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05, two-sided.', 'groupDescription': "Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.", 'statisticalMethod': 'Williams test for minimum effective dose', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.899', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05, two-sided.', 'groupDescription': "Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.", 'statisticalMethod': 'Williams test for minimum effective dose', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Post-randomization Day 22', 'description': 'Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary efficacy analysis was performed on the 167 randomized subjects that completed at least 4 days of the electronic pain diary during the last 7 days prior to the Day 22 or Early Termination Visit as per protocol. No imputation methods were used.'}, {'type': 'SECONDARY', 'title': 'Responder Analysis Between Active Treatment and Placebo Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 Placebo', 'description': 'Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system'}, {'id': 'OG001', 'title': '2 Gabapentin Low', 'description': 'Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'OG002', 'title': '3 Gabapentin Medium', 'description': 'Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'OG003', 'title': '4 Gabapentin High', 'description': 'Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': "The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': "The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Post-randomization Day 22', 'description': 'Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 170 randomized subjects were included as per protocol. Subjects experiencing an intolerable adverse event, discontinuing due to an adverse event or lack of efficacy, or not providing data were considered non-responders.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1 Placebo', 'description': 'Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system'}, {'id': 'OG001', 'title': '2 Gabapentin Low', 'description': 'Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'OG002', 'title': '3 Gabapentin Medium', 'description': 'Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'OG003', 'title': '4 Gabapentin High', 'description': 'Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.352', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'pValueComment': 'The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Post-randomization Day 29 (includes dose reduction)', 'description': 'Evaluation of adverse event profiles between placebo and active treatment groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects were included as per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Placebo (0mg/Day)', 'description': 'Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system'}, {'id': 'FG001', 'title': '2 Gabapentin Low (1mg/Day)', 'description': 'Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'FG002', 'title': '3 Gabapentin Medium (6mg/Day)', 'description': 'Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'FG003', 'title': '4 Gabapentin High (30mg/Day)', 'description': 'Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawn by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 254 subjects were enrolled into the study between December 2006 and October 2009.', 'preAssignmentDetails': 'During a 2-week screening period subjects were required to meet eligibility criteria including maintaining stable pain medications and demonstrating a numerical pain rating score of 6 or greater averaged over the last 7 days of screening. A total of 170 subjects met eligibility criteria, were implanted with an infusion system and were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '1 Placebo', 'description': 'Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system'}, {'id': 'BG001', 'title': '2 Gabapentin Low', 'description': 'Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'BG002', 'title': '3 Gabapentin Medium', 'description': 'Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'BG003', 'title': '4 Gabapentin High', 'description': 'Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '160', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '50.1', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '48.1', 'spread': '9.4', 'groupId': 'BG002'}, {'value': '48.3', 'spread': '11.1', 'groupId': 'BG003'}, {'value': '49.6', 'spread': '10.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'whyStopped': 'Study closed and subject follow-up completed following analysis of blinded study data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-19', 'studyFirstSubmitDate': '2006-12-20', 'resultsFirstSubmitDate': '2010-12-22', 'studyFirstSubmitQcDate': '2006-12-20', 'lastUpdatePostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-06', 'studyFirstPostDateStruct': {'date': '2006-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.', 'timeFrame': 'Baseline and Post-randomization Day 22', 'description': 'Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events', 'timeFrame': 'Randomization to Post-randomization Day 29 (includes dose reduction)', 'description': 'Evaluation of adverse event profiles between placebo and active treatment groups.'}], 'secondaryOutcomes': [{'measure': 'Responder Analysis Between Active Treatment and Placebo Groups.', 'timeFrame': 'Baseline to Post-randomization Day 22', 'description': 'Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Intractable Pain']}, 'referencesModule': {'references': [{'pmid': '23835590', 'type': 'DERIVED', 'citation': 'Rauck R, Coffey RJ, Schultz DM, Wallace MS, Webster LR, McCarville SE, Grigsby EJ, Page LM. Intrathecal gabapentin to treat chronic intractable noncancer pain. Anesthesiology. 2013 Sep;119(3):675-86. doi: 10.1097/ALN.0b013e3182a10fbf.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic pain below the neck present for a minimum of one year.\n* Diagnosis of at least one of the following:\n\n * back pain with or without leg pain,\n * post-herpetic neuralgia,\n * complex regional pain syndrome (CRPS) 1 or 2,\n * diabetic neuropathy,\n * or a general neuropathic condition; medically stable and able to undergo surgery for implantation of the drug infusion system.'}, 'identificationModule': {'nctId': 'NCT00414466', 'briefTitle': 'A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedtronicNeuro'}, 'officialTitle': 'A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal Gabapentin (MDT2004) in Subjects With Chronic, Intractable Pain.', 'orgStudyIdInfo': {'id': '1622'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (0mg/day)', 'description': 'Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system', 'interventionNames': ['Drug: Intraspinal Gabapentin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gabapentin Low (1mg/day)', 'description': 'Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose', 'interventionNames': ['Drug: Intraspinal Gabapentin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gabapentin Medium (6mg/day)', 'description': 'Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose', 'interventionNames': ['Drug: Intraspinal Gabapentin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gabapentin High (30mg/day)', 'description': 'Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose', 'interventionNames': ['Drug: Intraspinal Gabapentin']}], 'interventions': [{'name': 'Intraspinal Gabapentin', 'type': 'DRUG', 'description': 'Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.', 'armGroupLabels': ['Gabapentin High (30mg/day)', 'Gabapentin Low (1mg/day)', 'Gabapentin Medium (6mg/day)', 'Placebo (0mg/day)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Innovative Spine Care', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94558', 'city': 'Napa', 'state': 'California', 'country': 'United States', 'facility': 'Napa Pain Institute', 'geoPoint': {'lat': 38.29714, 'lon': -122.28553}}, {'zip': '34238', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Pain Medicine Research', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'WK River Cities Clinical Research Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'MAPS Applied Research Center', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'U B Neurosurgery, Inc.', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Pain Research of Oregon, LLC', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University, Neurosurgery Department', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hospital Center for Pain Management', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '75240', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pinnacle Pain Medicine', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Axis Spine Care/Texas Spine & Joint', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Lifetree Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedtronicNeuro', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}