Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-04-27 @ 12:00 PM
Study NCT ID:
NCT02357459
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2015-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631825', 'term': 'FX006'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'skelley@flexiontherapeutics.com', 'phone': '781-305-7142', 'title': 'Scott Kelley, VP of Medical Affairs', 'organization': 'Flexion Therapeutics'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Subsequent to completion of clinical studies extensive testing was performed to assess the actual FX006 dose delivered. It was determined that the FX006 delivered dose to the patient from an FX006 40 mg vial is 32 mg.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from Baseline Day 1 (following IA administration) through 24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'FX006 32mg', 'description': 'FX006: Single 5 mL IA injection', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 51, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 49, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 50, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Pneumonia:', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia:', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Large Intestine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Seizure Tonic Clonic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Unstable Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.12', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '-2.14', 'spread': '0.202', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.98', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '-0.49', 'pValueComment': 'The threshold for significance was \\<0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'statisticalMethod': 'longitudinal mixed repeated measures', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The analysis included all study weeks of data, and was not confined to only that at Baseline and Week 12. Descriptive statistics included number of observations, unadjusted mean, standard deviation, median, minimum and maximum, and baseline adjusted means from the mixed model. Treatment differences from control was presented, and estimated via least squares means from the analysis model along with 95% confidence intervals and associated 2-sided p-values.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 Weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm.'}, {'type': 'SECONDARY', 'title': 'Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-247.3', 'spread': '14.89', 'groupId': 'OG000'}, {'value': '-145.3', 'spread': '14.77', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 Weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'ADP Pain Scores * Week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm'}, {'type': 'SECONDARY', 'title': 'AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-247.3', 'spread': '14.89', 'groupId': 'OG000'}, {'value': '-231.9', 'spread': '14.85', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 12 Weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'ADP Pain Scores * Week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.12', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '-2.86', 'spread': '0.202', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through 12 Weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-432.5', 'spread': '30.14', 'groupId': 'OG000'}, {'value': '-297.0', 'spread': '29.90', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 24 Weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'ADP Pain Scores * Week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for TCA IR 40 mg Relative to Placebo was not a pre-specified Secondary Outcome and therefore not reported'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline to Each Week in Weekly Mean of the ADP Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection'}, {'id': 'OG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.200', 'groupId': 'OG001'}, {'value': '-2.13', 'spread': '0.201', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '-2.95', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-1.61', 'spread': '0.201', 'groupId': 'OG001'}, {'value': '-2.69', 'spread': '0.201', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '-3.20', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-1.66', 'spread': '0.201', 'groupId': 'OG001'}, {'value': '-2.93', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-3.23', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-1.84', 'spread': '0.200', 'groupId': 'OG001'}, {'value': '-3.11', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '-3.34', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '0.201', 'groupId': 'OG001'}, {'value': '-3.11', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-3.48', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-1.95', 'spread': '0.201', 'groupId': 'OG001'}, {'value': '-3.20', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '-3.48', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-2.01', 'spread': '0.201', 'groupId': 'OG001'}, {'value': '-3.03', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-3.48', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-1.96', 'spread': '0.202', 'groupId': 'OG001'}, {'value': '-3.04', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '-3.45', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-2.06', 'spread': '0.202', 'groupId': 'OG001'}, {'value': '-3.06', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '-3.31', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-2.08', 'spread': '0.201', 'groupId': 'OG001'}, {'value': '-3.07', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '-3.21', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '-2.13', 'spread': '0.202', 'groupId': 'OG001'}, {'value': '-3.01', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '-2.96', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '-2.21', 'spread': '0.202', 'groupId': 'OG001'}, {'value': '-2.87', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '-2.91', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '-2.18', 'spread': '0.202', 'groupId': 'OG001'}, {'value': '-2.73', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 15', 'categories': [{'measurements': [{'value': '-2.84', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '-2.12', 'spread': '0.202', 'groupId': 'OG001'}, {'value': '-2.75', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-2.73', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '-2.22', 'spread': '0.203', 'groupId': 'OG001'}, {'value': '-2.67', 'spread': '0.203', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'categories': [{'measurements': [{'value': '-2.66', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '-2.18', 'spread': '0.203', 'groupId': 'OG001'}, {'value': '-2.57', 'spread': '0.203', 'groupId': 'OG002'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '-2.60', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '-2.13', 'spread': '0.203', 'groupId': 'OG001'}, {'value': '-2.55', 'spread': '.0203', 'groupId': 'OG002'}]}]}, {'title': 'Week 19', 'categories': [{'measurements': [{'value': '-2.57', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '-2.19', 'spread': '0.203', 'groupId': 'OG001'}, {'value': '-2.48', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-2.44', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '-2.18', 'spread': '0.203', 'groupId': 'OG001'}, {'value': '-2.46', 'spread': '0.202', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'categories': [{'measurements': [{'value': '-2.27', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '-2.16', 'spread': '0.203', 'groupId': 'OG001'}, {'value': '-2.27', 'spread': '0.203', 'groupId': 'OG002'}]}]}, {'title': 'Week 22', 'categories': [{'measurements': [{'value': '-2.18', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '-2.20', 'spread': '0.204', 'groupId': 'OG001'}, {'value': '-2.29', 'spread': '0.203', 'groupId': 'OG002'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '-2.12', 'spread': '0.204', 'groupId': 'OG001'}, {'value': '-2.30', 'spread': '0.203', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-1.99', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '-2.16', 'spread': '0.203', 'groupId': 'OG001'}, {'value': '-2.18', 'spread': '0.203', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 1-11 & Weeks 13-24', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection'}, {'id': 'OG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.10', 'spread': '0.068', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.067', 'groupId': 'OG001'}, {'value': '-0.87', 'spread': '0.067', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.02', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.070', 'groupId': 'OG001'}, {'value': '-0.81', 'spread': '0.070', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '0.071', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '0.070', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.072', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.071', 'groupId': 'OG001'}, {'value': '-0.64', 'spread': '0.071', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.069', 'groupId': 'OG001'}, {'value': '-0.60', 'spread': '0.068', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '-0.49', 'spread': '0.070', 'groupId': 'OG001'}, {'value': '-0.56', 'spread': '0.069', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection'}, {'id': 'OG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.077', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '0.078', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.24', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.077', 'groupId': 'OG001'}, {'value': '-0.92', 'spread': '0.077', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-1.03', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.078', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '0.078', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.080', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '0.080', 'groupId': 'OG001'}, {'value': '-0.71', 'spread': '0.079', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '0.078', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.077', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.080', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.079', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '0.079', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection'}, {'id': 'OG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '.066', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '.065', 'groupId': 'OG001'}, {'value': '-0.87', 'spread': '.065', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.09', 'spread': '.068', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '.068', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '.068', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.93', 'spread': '.069', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '.068', 'groupId': 'OG001'}, {'value': '-0.72', 'spread': '.068', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '.069', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '.069', 'groupId': 'OG001'}, {'value': '-0.62', 'spread': '.069', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '.068', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '.068', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '.067', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '.069', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '.069', 'groupId': 'OG001'}, {'value': '-0.54', 'spread': '.068', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection'}, {'id': 'OG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '23.50', 'spread': '1.896', 'groupId': 'OG000'}, {'value': '8.93', 'spread': '1.832', 'groupId': 'OG001'}, {'value': '15.60', 'spread': '1.882', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '23.30', 'spread': '1.907', 'groupId': 'OG000'}, {'value': '10.70', 'spread': '1.856', 'groupId': 'OG001'}, {'value': '18.02', 'spread': '1.891', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '21.19', 'spread': '1.907', 'groupId': 'OG000'}, {'value': '12.22', 'spread': '1.869', 'groupId': 'OG001'}, {'value': '15.77', 'spread': '1.895', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '11.95', 'spread': '1.923', 'groupId': 'OG000'}, {'value': '10.25', 'spread': '1.878', 'groupId': 'OG001'}, {'value': '11.44', 'spread': '1.906', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 4, 8, 12, and 24', 'description': "The Knee injury and Osteoarthritis Outcome Score (KOOS) is a participant (patient)-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL).\n\nA Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Higher scores indicate better quality of life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection'}, {'id': 'OG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Week 15', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}]}, {'title': 'Week 19', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Week 22', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 1-24', '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': 'OTHER_PRE_SPECIFIED', 'title': 'Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection'}, {'id': 'OG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Week 15', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}, {'title': 'Week 19', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Week 22', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 1-24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Onset of Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection'}, {'id': 'OG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '24'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to >30% improvement (measured up to 30 days)', 'description': 'Time to onset of pain relief is defined as the time from administration of study drug to the first daily pain assessment showing \\>30% improvement from the weekly mean of the ADP scores at baseline', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FX006 32 mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection'}, {'id': 'OG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}], 'classes': [{'title': 'Week1', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.139', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '0.85', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '0.66', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '0.91', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.141', 'groupId': 'OG002'}]}]}, {'title': 'Week 15', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '0.141', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '0.141', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.95', 'spread': '0.141', 'groupId': 'OG002'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.141', 'groupId': 'OG002'}]}]}, {'title': 'Week 19', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.141', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '0.141', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '0.141', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '0.141', 'groupId': 'OG002'}]}]}, {'title': 'Week 22', 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.141', 'groupId': 'OG002'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '0.141', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.144', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '0.141', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 1-24', 'unitOfMeasure': 'tablets (1 tablet = 500 mg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FX006 32mg', 'description': '161 subjects received FX006 32 mg as a single 5 mL IA injection'}, {'id': 'FG001', 'title': 'Placebo', 'description': '162 subjects received normal saline as a single 5 mL IA injection.'}, {'id': 'FG002', 'title': 'TCA IR 40 mg', 'description': '161 subjects received TCA IR 40 mg as a single 1 mL IA injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '163'}, {'groupId': 'FG002', 'numSubjects': '162'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'groupId': 'FG002', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Patient Relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Instruction from PCP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Pre-planned Knee surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Job Commitments', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study took place at 41 centers across the United States, Canada, Australia, New Zealand, Hong Kong, Denmark, Romania, Estonia and Lithuania. Enrollment took approximately 6 months', 'preAssignmentDetails': 'Subjects were screened within 21 days of being randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '484', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'FX006 32mg', 'description': 'FX006: Single 5 mL IA injection'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Normal Saline: Single 5 mL IA injection'}, {'id': 'BG002', 'title': 'TCA IR 40 mg', 'description': 'TCA IR: Single 1 mL IA injection'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '9.52', 'groupId': 'BG000'}, {'value': '62.4', 'spread': '8.89', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '10.08', 'groupId': 'BG002'}, {'value': '62.1', 'spread': '9.49', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 486 patients were randomized in the study. Two patients, 1 each in the placebo group and 40 mg TCA IR group, were randomized and not treated. These 2 patients were not included in the FAS, Safety, or PP populations.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'dispFirstSubmitDate': '2017-01-27', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2015-02-03', 'dispFirstSubmitQcDate': '2017-01-27', 'resultsFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2015-02-05', 'dispFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-23', 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline to Each Week in Weekly Mean of the ADP Scores', 'timeFrame': 'Weeks 1-11 & Weeks 13-24', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, and 24', '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': 'Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', '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': 'Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', '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': 'Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24', 'timeFrame': 'Weeks 4, 8, 12, and 24', 'description': "The Knee injury and Osteoarthritis Outcome Score (KOOS) is a participant (patient)-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL).\n\nA Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Higher scores indicate better quality of life."}, {'measure': 'Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)', 'timeFrame': 'Weeks 1-24', '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 Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)', 'timeFrame': 'Weeks 1-24'}, {'measure': 'Time to Onset of Pain Relief', 'timeFrame': 'Baseline to >30% improvement (measured up to 30 days)', 'description': 'Time to onset of pain relief is defined as the time from administration of study drug to the first daily pain assessment showing \\>30% improvement from the weekly mean of the ADP scores at baseline'}, {'measure': 'Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)', 'timeFrame': 'Weeks 1-24'}], 'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo', 'timeFrame': 'Baseline and 12 Weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}], 'secondaryOutcomes': [{'measure': 'Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo', 'timeFrame': 'Baseline to 12 Weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR', 'timeFrame': 'Baseline to 12 Weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR', 'timeFrame': 'Baseline through 12 Weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}, {'measure': 'AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo', 'timeFrame': 'Baseline to 24 Weeks', 'description': 'The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates "no pain" and 10 indicates "pain as bad as you can imagine."'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee', 'pain', 'corticosteroid', 'intra-articular', 'injection'], 'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'references': [{'pmid': '34791634', 'type': 'DERIVED', 'citation': 'Ross E, Katz NP, Conaghan PG, Kivitz A, Turk DC, Spitzer AI, Jones DG, Lanier RK, Cinar A, Lufkin J, Kelley SD. Improved Treatment Effect of Triamcinolone Acetonide Extended-Release in Patients with Concordant Baseline Pain Scores on the Average Daily Pain and Western Ontario and McMaster Universities Osteoarthritis Index Pain Scales. Pain Ther. 2022 Mar;11(1):289-302. doi: 10.1007/s40122-021-00335-z. Epub 2021 Nov 17.'}, {'pmid': '30968336', 'type': 'DERIVED', 'citation': 'Langworthy MJ, Conaghan PG, Ruane JJ, Kivitz AJ, Lufkin J, Cinar A, Kelley SD. Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis. Adv Ther. 2019 Jun;36(6):1398-1411. doi: 10.1007/s12325-019-00944-3. Epub 2019 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.', 'detailedDescription': 'This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:\n\n* 32 mg FX006,\n* normal saline (placebo), or\n* 40 mg TCA IR.\n\nRandomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to \\<6, 6 to \\<7, and ≥7.\n\nEach patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 \\[baseline\\], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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* Has symptoms associated with OA of the index knee for at least 6 months prior to Screening\n* Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA\n* Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray\n* Index knee pain for \\> 15 days over the last month\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\nExclusion Criteria:\n\n* Any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iIpsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal or greater than the index knee pain)\n* Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease\n* History of infection in the index knee\n* Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening\n* Unstable joint within 12 months of screening\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* Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening\n* Any other IA investigational drug/biologic within 6 months of Screening\n* Prior use of FX006\n* Women of child-bearing potential not using effective contraception or who are pregnant or nursing"}, 'identificationModule': {'nctId': 'NCT02357459', 'briefTitle': 'Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pacira Pharmaceuticals, Inc'}, 'officialTitle': 'A Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'FX006-2014-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FX006 32mg', 'description': 'Single 5 mL intra-articular (IA) injection Extended-release Formulation', 'interventionNames': ['Drug: FX006']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Single 5 mL intra-articular (IA) injection', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TCA IR 40 mg', 'description': 'Single 1 mL intra-articular (IA) injection TCA IR 40 mg: Immediate-release formulation', 'interventionNames': ['Drug: TCA IR 40']}], 'interventions': [{'name': 'FX006', 'type': 'DRUG', 'otherNames': ['Zilretta'], 'description': 'Single 5 mL IA injection', 'armGroupLabels': ['FX006 32mg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'description': 'Single 5 mL IA injection', 'armGroupLabels': ['Normal Saline']}, {'name': 'TCA IR 40', 'type': 'DRUG', 'otherNames': ['Kenalog®-40 Injection', 'Kenacort-A 40', 'Triamcinolone Acetonide Crystalline Suspension (TAcs)'], 'description': 'Single 1 mL IA injection', 'armGroupLabels': ['TCA IR 40 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 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