Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2026-01-06 @ 6:07 AM
Study NCT ID:
NCT04123561
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2019-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tttai@tlcbio.com', 'phone': '+886 2 2655 7377', 'title': 'Dr. Tien-Tzu Tai', 'phoneExt': '801', 'organization': 'Taiwan Liposome Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time the subject signs the ICF through the end of the study. The AE collected duration will be up to 56 weeks, including a Screening period of up to 4 weeks before randomization, Injection 1 Period of 24 weeks and Injection 2 Period of 28 weeks.', 'description': 'All adverse events (AEs) were coded using the MedDRA v23.1 terminology to classify corresponding MedDRA System organ class (SOC) and preferred term (PT) for standardization and summary purposes.', 'eventGroups': [{'id': 'EG000', 'title': 'TLC599 12 mg', 'description': 'TLC599 :1 mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)', 'otherNumAtRisk': 252, 'deathsNumAtRisk': 252, 'otherNumAffected': 73, 'seriousNumAtRisk': 252, 'deathsNumAffected': 1, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'DSP 4 mg', 'description': 'Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 33, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Normal saline: 1 mL IA injection', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 28, 'seriousNumAtRisk': 126, 'deathsNumAffected': 1, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hiatus hemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cerebral venous sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 252, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.968', 'groupId': 'OG000', 'lowerLimit': '-1.060', 'upperLimit': '-0.877'}, {'value': '-0.798', 'groupId': 'OG001', 'lowerLimit': '-0.930', 'upperLimit': '-0.665'}]}]}], 'analyses': [{'pValue': '0.0372', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference (LSMD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.171', 'ciLowerLimit': '-0.331', 'ciUpperLimit': '-0.010', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0819', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Parameters estimated via REML using the Newton-Raphson algorithm, and the Kenward-Roger method calculates denominator degrees of freedom.', 'nonInferiorityComment': 'The primary efficacy endpoint is defined as the change from Injection 1 Baseline in WOMAC Pain on a normalized scale of 0-4 at Week 12 between the randomized TLC599 12mg and Placebo groups.\n\nThe least-squares mean, alongside its corresponding 95% confidence interval, was used to estimate the treatment difference between TLC599 and Placebo, utilizing two-sided p-values.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.929', 'spread': '0.0492', 'groupId': 'OG000'}, {'value': '-0.798', 'spread': '0.0704', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.873', 'spread': '0.0489', 'groupId': 'OG000'}, {'value': '-0.749', 'spread': '0.0703', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 20', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.845', 'spread': '0.0496', 'groupId': 'OG000'}, {'value': '-0.688', 'spread': '0.0719', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.964', 'spread': '0.0545', 'groupId': 'OG000'}, {'value': '-0.882', 'spread': '0.0791', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.903', 'spread': '0.0470', 'groupId': 'OG000'}, {'value': '-0.735', 'spread': '0.0681', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'PGIC at Week 12 for TLC599 12mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '2.554', 'spread': '0.0739', 'groupId': 'OG000'}, {'value': '2.791', 'spread': '0.1059', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 12', 'description': 'Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients\' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '15.568', 'spread': '3.1902', 'groupId': 'OG000'}, {'value': '29.803', 'spread': '4.5893', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'through Week 12', 'description': 'Rescue medication use of acetaminophen was provided and recorded in electronic patient diaries. Weekly Total Acetaminophen consumption was tabulated for analysis on a weekly basis, starting from the first date of study drug injection: (Day 1, 8), (Day 8, 15), and so on. Average daily use (e.g., Weekly Total Acetaminophen Consumption divided by 7) was computed to produce Weekly Average Daily Acetaminophen Consumption.', 'unitOfMeasure': 'tablets per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '39.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4 through 12', 'description': 'Durable responder endpoints were derived based on the imputed WOMAC pain data. A subject which has ≥ 30% decrease in pain response from Baseline at each visit within a specified time period (x-y). This was derived for patients based on the Injection 1 Baseline for the following time period (x-y): (4-12).', 'unitOfMeasure': 'percentage of responder', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.907', 'spread': '0.0540', 'groupId': 'OG000'}, {'value': '-0.787', 'spread': '0.0774', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 36', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'PGIC at Week 36 for TLC599 12mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '2.635', 'spread': '0.0883', 'groupId': 'OG000'}, {'value': '2.738', 'spread': '0.1288', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 36', 'description': 'Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients\' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12 mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'DSP 4 mg', 'description': 'Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.968', 'spread': '0.0467', 'groupId': 'OG000'}, {'value': '-0.933', 'spread': '0.0667', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TLC599 12mg', 'description': 'TLC599 :1mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal saline: 1mL IA injection'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.928', 'spread': '0.0580', 'groupId': 'OG000'}, {'value': '-0.934', 'spread': '0.0820', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TLC599 12 mg', 'description': 'TLC599: 1 mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'FG001', 'title': 'DSP 4 mg', 'description': 'DSP 4 mg: 1 mL IA injection\n\nDexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Normal saline: 1 mL IA injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '252'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'A surgical procedure or IA administration in the index knee', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were screened for study eligibility at multiple study centers in the United States (US) and Australia.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '504', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'TLC599 12 mg', 'description': 'TLC599:1 mL IA injection\n\nTLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)'}, {'id': 'BG001', 'title': 'DSP 4 mg', 'description': 'DSP 4mg:1 mL IA injection Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Normal saline: 1 mL IA injection'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '322', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '182', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '8.50', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '9.50', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '9.30', 'groupId': 'BG002'}, {'value': '61.0', 'spread': '8.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '422', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '447', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mean body mass index', 'classes': [{'categories': [{'measurements': [{'value': '31.13', 'spread': '4.772', 'groupId': 'BG000'}, {'value': '31.80', 'spread': '5.144', 'groupId': 'BG001'}, {'value': '31.33', 'spread': '4.603', 'groupId': 'BG002'}, {'value': '31.35', 'spread': '4.825', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body measurements - Mean body mass index (Kg/m\\^2)', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean weight', 'classes': [{'categories': [{'measurements': [{'value': '89.30', 'spread': '17.816', 'groupId': 'BG000'}, {'value': '91.71', 'spread': '19.425', 'groupId': 'BG001'}, {'value': '89.55', 'spread': '17.750', 'groupId': 'BG002'}, {'value': '89.96', 'spread': '18.207', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body measurements - Mean weight (kg)', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Full Analysis Set (FAS) includes all randomized patients who receive study drug at baseline.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-09', 'size': 17682827, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-18T23:15', 'hasProtocol': True}]}}, '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': 504}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2019-10-09', 'resultsFirstSubmitDate': '2024-04-19', 'studyFirstSubmitQcDate': '2019-10-09', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-12', 'studyFirstPostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in WOMAC Pain at Week 12 for TLC599 12 mg Versus Placebo', 'timeFrame': 'Baseline, Week 12', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in WOMAC Pain at Week 16 for TLC599 12 mg Versus Placebo', 'timeFrame': 'Baseline, Week 16', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.'}, {'measure': 'Change From Baseline in WOMAC Pain at Week 20 for TLC599 12 mg Versus Placebo', 'timeFrame': 'Baseline, Week 20', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.'}, {'measure': 'Change From Baseline in WOMAC Pain at Week 24 for TLC599 12mg Versus Placebo', 'timeFrame': 'Baseline, Week 24', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.'}, {'measure': 'Change From Baseline in WOMAC Pain at Week 36 for TLC599 12mg Versus Placebo', 'timeFrame': 'Baseline, Week 36', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.'}, {'measure': 'Change From Baseline in WOMAC Function at Week 12 for TLC599 12mg Versus Placebo', 'timeFrame': 'Baseline, Week 12', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.'}, {'measure': 'PGIC at Week 12 for TLC599 12mg Versus Placebo', 'timeFrame': 'Week 12', 'description': 'Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients\' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse".'}, {'measure': 'Total Rescue Acetaminophen Consumption Through Week 12 for TLC599 12mg Versus Placebo', 'timeFrame': 'through Week 12', 'description': 'Rescue medication use of acetaminophen was provided and recorded in electronic patient diaries. Weekly Total Acetaminophen consumption was tabulated for analysis on a weekly basis, starting from the first date of study drug injection: (Day 1, 8), (Day 8, 15), and so on. Average daily use (e.g., Weekly Total Acetaminophen Consumption divided by 7) was computed to produce Weekly Average Daily Acetaminophen Consumption.'}, {'measure': 'Durable Responder With ≥30% Decrease in WOMAC Pain From Baseline for Weeks 4 Through 12 for TLC599 12mg Versus Placebo', 'timeFrame': 'Weeks 4 through 12', 'description': 'Durable responder endpoints were derived based on the imputed WOMAC pain data. A subject which has ≥ 30% decrease in pain response from Baseline at each visit within a specified time period (x-y). This was derived for patients based on the Injection 1 Baseline for the following time period (x-y): (4-12).'}, {'measure': 'Change From Baseline in WOMAC Function at Week 36 for TLC599 12mg Versus Placebo', 'timeFrame': 'Baseline, Week 36', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.'}, {'measure': 'PGIC at Week 36 for TLC599 12mg Versus Placebo', 'timeFrame': 'Week 36', 'description': 'Patient Global Impression of Change (PGIC) is a single-item question that measures change in patients\' overall improvement rated on a 7-point scale including "1 = very much improved," "2 = much improved," "3 = minimally improved," "4 = no change," "5 = minimally worse," "6 = much worse," or "7 = very much worse".'}, {'measure': 'Change From Baseline in WOMAC Pain at Week 12 for TLC599 12mg Versus DSP 4 mg', 'timeFrame': 'Baseline, Week 12', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.'}, {'measure': 'Change From Baseline in WOMAC Pain at Week 52 for TLC599 12mg Versus Placebo', 'timeFrame': 'Baseline, Week 52', 'description': 'The WOMAC (Western Ontario \\& McMaster Universities Osteoarthritis Index, Version 3.1) consists of 24 questions rated on a 0-4 Likert scale, totaling a score from 0-96, reflecting the previous 24 hours. Sub-scale scores for Pain (5 items, a 0-20 scale), Stiffness (2 items, a 0-8 scale), and Physical Function (17 items, a 0-68 scale) are summed to calculate the WOMAC Composite score. Both composite and sub-scale scores are normalized to a 0-4 scale for analysis, with higher scores indicating greater severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.', 'detailedDescription': 'This is a Phase 3 randomized, double-blind, placebo- and active comparator-controlled pivotal study. Approximately 500 adult patients with moderate to severe pain due to OA of the knee will be enrolled and randomized. All patients will be followed for a total of 52 weeks. Efficacy and safety of 2 doses of TLC599 will be evaluated in comparison to Placebo and DSP through Week 52.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nMale or female ≥40 years of age. BMI ≤ 40 kg/m2. Radiographically documented OA with Kellgren-Lawrence severity Grade 2 or 3 and associated symptoms Patient-reported pain with NRS score ≥4 (on a 0-10 scale) Able to read, understand, and sign the informed consent form, communicate with the investigator, complete study diaries, and understand and comply with protocol requirements.\n\nExclusion Criteria:\n\nRecent use of IA or systemic corticosteroids Patient who is not ambulatory Any surgery or arthroscopy in the index knee within 12 months Any condition that could possibly confound the patient's assessment of index knee pain Substance abuse disorder, or positive urine drug test for illegal drug substances History of acquired or congenital immunodeficiency diseases History of treated malignancy which is disease free for ≤5 years Known allergy or hypersensitivity to the study drugs or their components"}, 'identificationModule': {'nctId': 'NCT04123561', 'acronym': 'EXCELLENCE', 'briefTitle': 'Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiwan Liposome Company'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'TLC599A3005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TLC599', 'description': 'TLC599 (1mL) IA injection', 'interventionNames': ['Drug: TLC599']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone sodium phosphate', 'description': 'DSP 4mg (1mL) IA injection', 'interventionNames': ['Drug: TLC599', 'Drug: DSP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'Normal saline (1mL) IA injection', 'interventionNames': ['Other: Normal Saline']}], 'interventions': [{'name': 'TLC599', 'type': 'DRUG', 'otherNames': ['TLC599 Injection'], 'description': 'TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)', 'armGroupLabels': ['Dexamethasone sodium phosphate', 'TLC599']}, {'name': 'DSP', 'type': 'DRUG', 'otherNames': ['Dexamethasone Sodium Phosphate'], 'description': 'Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.', 'armGroupLabels': ['Dexamethasone sodium phosphate']}, {'name': 'Normal Saline', 'type': 'OTHER', 'description': '0.9% normal saline', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Research, Inc', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Affinity Orthopedic Specialists Llc', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35660', 'city': 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'facility': 'Colin Bayliss Research and Teaching Unit', 'geoPoint': {'lat': -31.97619, 'lon': 115.90525}}], 'overallOfficials': [{'name': 'Carl Brown, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taiwan Liposome Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiwan Liposome Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}