Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT01487161
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2011-12-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of FX006 in Patients With Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
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Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'skelley@flexiontherapeutics.com', 'phone': '781-305-7142', 'title': 'Scott Kelley, VP of Medical Affairs', 'organization': 'Flexion Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from post injection on Day 1 through Day 85', 'eventGroups': [{'id': 'EG000', 'title': 'FX006 10 mg', 'description': 'FX006: Single 3 mL IA injection', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 13, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FX006 40 mg', 'description': 'FX006: Single 3 mL IA injection', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 16, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 22, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'TCA IR (40 mg)', 'description': 'TCA IR: Single 1 mL IA injection', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 22, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutrophil Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'White Blood Cell Count Inreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subcutaneous Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1249', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.5', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.2', 'statisticalMethod': 'Longitudinal mixed effect model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.6', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.3', 'statisticalMethod': 'Longitudinal mixed effect model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '10 weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5541', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.8', 'statisticalMethod': 'Longitudinal mixed effect model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 10 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'FX006 40 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'title': '8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': '10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': '12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '0.33', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 8, 10 and 12', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 10 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'FX006 40 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG002', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG003', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '0.24', 'groupId': 'OG002'}, {'value': '-3.1', 'spread': '0.26', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '0.29', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '0.29', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '0.28', 'groupId': 'OG003'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '0.30', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '0.30', 'groupId': 'OG003'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '-3.3', 'spread': '0.30', 'groupId': 'OG003'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '0.29', 'groupId': 'OG002'}, {'value': '-3.3', 'spread': '0.32', 'groupId': 'OG003'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '0.29', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '0.32', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 1-7 and Week 9 and 11', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.'}, {'type': 'SECONDARY', 'title': 'WOMAC A (Pain Subscale) Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 10 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'FX006 40 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG002', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG003', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '0.098', 'groupId': 'OG001'}, {'value': '-1.16', 'spread': '0.097', 'groupId': 'OG002'}, {'value': '-0.96', 'spread': '0.108', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 10 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'FX006 40 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG002', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG003', 'title': 'TCA IR 40 mg', 'description': 'FX006: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '0.11', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '0.13', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WOMAC B (Stiffness Subscale) Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 10 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'FX006 40 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG002', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG003', 'title': 'TCA IR (40 mg)', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.37', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '0.112', 'groupId': 'OG001'}, {'value': '-1.24', 'spread': '0.111', 'groupId': 'OG002'}, {'value': '-0.99', 'spread': '0.124', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WOMAC C (Function Subscale) Change From Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 10 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'FX006 40 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG002', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG003', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.22', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '0.096', 'groupId': 'OG001'}, {'value': '-1.13', 'spread': '0.095', 'groupId': 'OG002'}, {'value': '-0.94', 'spread': '0.106', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': 'The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Responders According to OMERACT-OARSI Criteria at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 10 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'FX006 40 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG002', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG003', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. 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'OG002', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG003', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': 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The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Change Scores at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 10 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'FX006 40 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG002', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG003', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '0.17', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'description': "The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 10 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG001', 'title': 'FX006 40 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG002', 'title': 'FX006 60 mg', 'description': 'FX006: Single 3 mL IA injection'}, {'id': 'OG003', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.24', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '8 weeks', 'unitOfMeasure': 'tablets (1tablet= 500 mg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FX006 10 mg', 'description': '58 subjects received FX006 10 mg as a single 3 mL IA injection.'}, {'id': 'FG001', 'title': 'FX006 40 mg', 'description': '59 subjects received FX006 40 mg as a single 3 mL IA injection.'}, {'id': 'FG002', 'title': 'FX006 60 mg', 'description': '60 subjects received FX006 60 mg as a single 3 mL IA injection.'}, {'id': 'FG003', 'title': 'TCA IR (40 mg)', 'description': '51 subjects received TCA IR 40 mg as a single 1 mL IA injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'missing data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study took place at 22 centers across the United States, Canada and Australia. Enrollment took approximately 7 months.', 'preAssignmentDetails': 'Subjects were screened within 21 days of being randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '228', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'FX006 10 mg', 'description': 'Single 3 mL IA injection'}, {'id': 'BG001', 'title': 'FX006 40 mg', 'description': 'Single 3 mL IA injection'}, {'id': 'BG002', 'title': 'FX006 60 mg', 'description': 'Single 3 mL IA injection'}, {'id': 'BG003', 'title': 'TCA IR (40 mg)', 'description': 'Single 1 mL IA injection'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '82'}, {'value': '60.9', 'groupId': 'BG001', 'lowerLimit': '40', 'upperLimit': '80'}, {'value': '61.9', 'groupId': 'BG002', 'lowerLimit': '44', 'upperLimit': '86'}, {'value': '61.6', 'groupId': 'BG003', 'lowerLimit': '42', 'upperLimit': '83'}, {'value': '61.5', 'groupId': 'BG004', 'lowerLimit': '40', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 229 patients were randomized to treatment in this study. 228 of 229 randomized patients received treatment and were included in the Safety Population; 1 patient randomized to the TCA IR group withdrew consent before receiving study treatment and was excluded.'}}, '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': 229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'dispFirstSubmitDate': '2015-03-16', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2011-12-05', 'dispFirstSubmitQcDate': '2015-03-16', 'resultsFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2011-12-05', 'dispFirstPostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-13', 'studyFirstPostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg', 'timeFrame': '8 weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg', 'timeFrame': '10 weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg', 'timeFrame': '12 weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg', 'timeFrame': 'Weeks 8, 10 and 12', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.', 'timeFrame': 'Weeks 1-7 and Week 9 and 11', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'WOMAC A (Pain Subscale) Change From Baseline at Week 8', 'timeFrame': '8 weeks', 'description': 'The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8', 'timeFrame': '8 weeks', 'description': 'The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'WOMAC B (Stiffness Subscale) Change From Baseline at Week 8', 'timeFrame': '8 weeks', 'description': 'The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'WOMAC C (Function Subscale) Change From Baseline at Week 8', 'timeFrame': '8 weeks', 'description': 'The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'Percent of Responders According to OMERACT-OARSI Criteria at Week 8', 'timeFrame': '8 weeks', 'description': 'Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. Responders are defined as participants with high improvement in pain or function.'}, {'measure': 'Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8', 'timeFrame': '8 weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8', 'timeFrame': '8 weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8', 'timeFrame': '8 weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'Patient Global Impression of Change Scores at Week 8', 'timeFrame': 'Week 8', 'description': "The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status."}, {'measure': 'Clinical Global Impression of Change Scores at Week 8', 'timeFrame': '8 weeks', 'description': "The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status."}, {'measure': 'Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee', 'pain', 'corticosteroid', 'intra-articular', 'injection'], 'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://journals.lww.com/jbjsjournal/Abstract/2015/06030/An_Intra_Articular,_Extended_Release_Formulation.1.aspx', 'label': 'Journal of Bone \\& Joint Surgery - American Volume: 3 June 2015 - Volume 97 - Issue 11 - p 877-888'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.', 'detailedDescription': 'Study FX006-2011-001 was a multi-center, randomized, double-blind, active comparator, parallel-group, single-dose study designed to assess the magnitude and duration of pain relief of three doses (10, 40, and 60 mg) of FX006, an extended-release formulation of TCA, relative to commercially-available TCA IR.\n\nThe general tolerability of a single injection of FX006 also was assessed.\n\nSecondary objectives included exploration of the effect of FX006 on functional improvement, responder status, time to onset of pain relief, global impressions of change, and consumption of analgesic medications and evaluation of the PK profile of single injection of the three dose levels of FX006.\n\nThe study was planned to be conducted in up to 224 male and female patients ≥40 years of age with OA of the knee enrolled at 22 study centers in the US, Australia, and Canada.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions\n* Male or female \\>=40 years of age\n* Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period\n* Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)\n* Body mass index (BMI) ≤ 40 kg/m2\n* Willingness to abstain from use of restricted medications\n\nMain Exclusion Criteria\n\n* Ipsilateral hip OA\n* Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee\n* History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis\n* History of arthritides due to crystals (e.g., gout, pseudogout)\n* History of infection in the index joint\n* Clinical signs and symptoms of active knee infection or crystal disease of the index knee\n* Presence of surgical hardware or other foreign body in the index knee\n* Unstable joint (such as a torn anterior cruciate ligament)\n* IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening\n* IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening\n* Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month of Screening\n* Prior arthroscopic or open surgery of the index knee within 12 months of Screening\n* Planned/anticipated surgery of the index knee during the study period\n* Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ\n* Insulin-dependent diabetes\n* Active psychiatric disorder including psychosis and major depressive disorder\n* History of or active Cushing's syndrome\n* Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)\n* Skin breakdown at the knee where the injection would take place\n* Women of child-bearing potential not using effective contraception or who are pregnant or nursing"}, 'identificationModule': {'nctId': 'NCT01487161', 'briefTitle': 'Study of FX006 in Patients With Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pacira Pharmaceuticals, Inc'}, 'officialTitle': 'A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'FX006-2011-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FX006 10 mg', 'description': 'Single 3 mL intra-articular (IA) injection Extended-Release Formulation', 'interventionNames': ['Drug: FX006']}, {'type': 'EXPERIMENTAL', 'label': 'FX006 40 mg', 'description': 'Single 3 mL intra-articular (IA) injection Extended-Release Formulation', 'interventionNames': ['Drug: FX006']}, {'type': 'EXPERIMENTAL', 'label': 'FX006 60 mg', 'description': 'Single 3mL intra-articular (IA) injection Extended-Release Formulation', 'interventionNames': ['Drug: FX006']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TCA IR 40 mg', 'description': 'Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide', 'interventionNames': ['Drug: TCA IR']}], 'interventions': [{'name': 'FX006', 'type': 'DRUG', 'description': 'Single 3 mL intra-articular injection', 'armGroupLabels': ['FX006 10 mg', 'FX006 40 mg', 'FX006 60 mg']}, {'name': 'TCA IR', 'type': 'DRUG', 'otherNames': ['Kenalog®-40 Injection', 'Kenacort-A 40', 'Triamcinolone Acetonide Crystalline Suspension (TAcs)'], 'description': 'Single 1 mL intra-articular injection', 'armGroupLabels': ['TCA IR 40 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'city': 'Broadmeadow', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -32.92371, 'lon': 151.72849}}, {'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'city': 'Kippa-Ring', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.22586, 'lon': 153.0835}}, {'city': 'Maroochydore', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -26.66008, 'lon': 153.09953}}, {'city': 'Sherwood', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.53034, 'lon': 152.98216}}, {'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Malvern East', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.87397, 'lon': 145.04253}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'city': "Saint Catherine's", 'state': 'Ontario', 'country': 'Canada'}, {'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'city': 'Thornhill', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.80011, 'lon': -79.4163}}, {'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}], 'overallOfficials': [{'name': 'Neil Bodick, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Flexion Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacira Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}