Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT00939094
Status:
TERMINATED
Last Update Posted:
2012-09-27
First Post:
2009-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AZD2066 Neuropathic Pain - Mechanical Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D006930', 'term': 'Hyperalgesia'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous 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'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587779', 'term': 'AZD2066'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'No publication or presentation with respect to the study until the earlier of 1) publication of the first Multi-Center Publication and 2) the second anniversary of the completion, or termination of the study.\n\nSponsor to review at least 60 days prior submission. Sponsor can withhold material for submission for additional 90 days', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination of study for safety reasons leading to fewer subjects analyzed than originally planned.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule', 'otherNumAtRisk': 42, 'otherNumAffected': 30, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule', 'otherNumAtRisk': 44, 'otherNumAffected': 15, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule'}, {'id': 'OG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.14', 'spread': '0.358', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '0.337', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)', 'description': 'Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.', 'unitOfMeasure': 'Scores (units) on NRS', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule'}, {'id': 'OG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'NRS pain intensity score reduction=(change from baseline at Day 28/baseline)\\*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)\\*100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule'}, {'id': 'OG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'Pain intensity score reduction=(change from baseline Day 28/baseline)\\*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)\\*100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule'}, {'id': 'OG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'PGIC scale ranges from 1-7 where 1=Very much improved and 7=Very much worse Responder=Patient with a response of " much improved" or "very much improved" Responder rate=(no. of responders/total no. of patients)\\*100', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule'}, {'id': 'OG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.39', 'spread': '1.278', 'groupId': 'OG000'}, {'value': '-3.98', 'spread': '1.188', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'Sensory index=sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index=0-33 (higher score represents a worse condition).\n\nChange from baseline (measured prior to randomization) to Day 28 was calculated.', 'unitOfMeasure': 'Scores (units) on SF-MPQ Sensory Index', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in SF-MPQ Affective Index From Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule'}, {'id': 'OG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.50', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'Affective index=sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).\n\nChange from baseline (measured prior to randomization) to Day 28 was calculated.', 'unitOfMeasure': 'Scores (units) on SF-MPQ Affective Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule'}, {'id': 'OG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.12', 'spread': '0.385', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '0.360', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.', 'unitOfMeasure': 'Scores (units) on BPI-SF pain severity', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BPI-SF Pain Interference From Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule'}, {'id': 'OG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.98', 'spread': '0.376', 'groupId': 'OG000'}, {'value': '-1.72', 'spread': '0.360', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '28 days', 'description': 'Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a NRS 0-10, where 0=No interference and 10=Interferes completely.', 'unitOfMeasure': 'Scores on BPI-SF pain interference', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule'}, {'id': 'FG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Eligibility criteria not fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Severe non-compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study stopped by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Abnormal ECG findings', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This multicenter study was conducted between August 2009 and November 2010 in the United States.', 'preAssignmentDetails': 'The study had an enrolment phase of up to 35 days (including washout and baseline periods), a 28-day treatment phase, and a follow-up phase of 7 days (for men and women not of childbearing potential) or 28 days (for women of childbearing potential). Patients randomized to AZD2066 received AZD2066 12 mg from Days 1 to 4 and 18 mg from Days 5 to 28.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'A - AZD2066', 'description': 'AZD2066, 12 mg capsule'}, {'id': 'BG001', 'title': '2 - Placebo', 'description': 'Placebo, capsule'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '9.25', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '14.31', 'groupId': 'BG001'}, {'value': '58.7', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-28', 'studyFirstSubmitDate': '2009-07-13', 'resultsFirstSubmitDate': '2012-08-28', 'studyFirstSubmitQcDate': '2009-07-13', 'lastUpdatePostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-28', 'studyFirstPostDateStruct': {'date': '2009-07-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment', 'timeFrame': 'Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)', 'description': 'Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28', 'timeFrame': '28 days', 'description': 'NRS pain intensity score reduction=(change from baseline at Day 28/baseline)\\*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)\\*100'}, {'measure': 'Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28', 'timeFrame': '28 days', 'description': 'Pain intensity score reduction=(change from baseline Day 28/baseline)\\*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)\\*100'}, {'measure': 'Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28', 'timeFrame': '28 days', 'description': 'PGIC scale ranges from 1-7 where 1=Very much improved and 7=Very much worse Responder=Patient with a response of " much improved" or "very much improved" Responder rate=(no. of responders/total no. of patients)\\*100'}, {'measure': 'Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28', 'timeFrame': '28 days', 'description': 'Sensory index=sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index=0-33 (higher score represents a worse condition).\n\nChange from baseline (measured prior to randomization) to Day 28 was calculated.'}, {'measure': 'Change in SF-MPQ Affective Index From Baseline to Day 28', 'timeFrame': '28 days', 'description': 'Affective index=sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).\n\nChange from baseline (measured prior to randomization) to Day 28 was calculated.'}, {'measure': 'Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28', 'timeFrame': '28 days', 'description': 'Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.'}, {'measure': 'Change in BPI-SF Pain Interference From Baseline to Day 28', 'timeFrame': '28 days', 'description': 'Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a NRS 0-10, where 0=No interference and 10=Interferes completely.'}]}, 'conditionsModule': {'keywords': ['Pain, Mechanical Hypersensitivity', 'Allodynia', 'Efficacy', 'analgesia', 'Neuropathic'], 'conditions': ['Neuropathic Pain', 'Mechanical Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures.\n* Male or non-fertile females\n* Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia.\n\nExclusion Criteria:\n\n* Other pain that may confound assessment of neuropathic pain.\n* Diagnosis of any severe neurological disease.\n* History of significant psychiatric disease/condition and/or history of psychotic disorders among first degree relatives.'}, 'identificationModule': {'nctId': 'NCT00939094', 'acronym': 'NP-MH', 'briefTitle': 'AZD2066 Neuropathic Pain - Mechanical Hypersensitivity', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2066 Compared to Placebo in Peripheral Neuropathic Pain Patients With Mechanical Hypersensitivity', 'orgStudyIdInfo': {'id': 'D0475C00016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: AZD2066']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD2066', 'type': 'DRUG', 'description': 'Capsule, once daily', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule, once daily', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Walnut 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