Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-29 @ 3:18 AM
Study NCT ID:
NCT00653432
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2008-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kmezger@anika.com', 'phone': '781.457.9000', 'title': 'Kara Mezger, Exec Director Clinical Affairs', 'organization': 'Anika Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '26 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection', 'otherNumAtRisk': 184, 'otherNumAffected': 121, 'seriousNumAtRisk': 184, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline', 'otherNumAtRisk': 185, 'otherNumAffected': 123, 'seriousNumAtRisk': 185, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stomach Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Back Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Thermal Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 59, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 44, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 26, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 25, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 20, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 24, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Synovial Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 39, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 56, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Migrane', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rhonchi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 184, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '1.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'OG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '62.57', 'groupId': 'OG000'}, {'value': '56.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1450', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Ordinal GEE Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks', 'description': 'The primary endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved \\>= a 40% improvement (reduction) in the WOMAC Pain Score and show at least 15 mm improvement (reduction) in the WOMAC Pain Score from baseline through 12 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. The primary endpoint uses the ITT population that has data available for both baseline and 12 week time points.', 'unitOfMeasure': 'Percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.'}, {'type': 'SECONDARY', 'title': 'Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'OG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'classes': [{'title': 'Change from Baseline in Evaluator Global 12 weeks', 'categories': [{'measurements': [{'value': '-28.6', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '-26.4', 'spread': '26.4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Evaluator Global', 'categories': [{'measurements': [{'value': '59.1', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '58.9', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': '12 Week Evaluator Global', 'categories': [{'measurements': [{'value': '30.4', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '23.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5824', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Ordinal GEE Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Comparison of the change of the Evaluator Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Evaluator Global Assessment is done by the Blinded Evaluator, and answers the question "Considering all the ways the osteoarthritis in the patient\'s index knee affect him/her, what is your assessment of how much the patient\'s knee is bothering him/her today?" The Evaluator Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS Scale), where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.'}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment Change From Baseline Through Week 12 (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'OG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'classes': [{'title': 'Change from Baseline in Patient Global 12 weeks', 'categories': [{'measurements': [{'value': '-28.8', 'spread': '30.8', 'groupId': 'OG000'}, {'value': '-28.9', 'spread': '27.7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Patient Global', 'categories': [{'measurements': [{'value': '62.9', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': '12 Week Patient Global', 'categories': [{'measurements': [{'value': '33.7', 'spread': '25.0', 'groupId': 'OG000'}, {'value': '33.2', 'spread': '24.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9136', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Ordinal GEE Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Comparison of the change of the Patient Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Patient Global Assessment is done by the patient, and answers the question "Considering all the ways the osteoarthritis in your study knee affects you, what is your assessment of how much your study knee is bothering you today?" The Patient Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS Scale), where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.'}, {'type': 'SECONDARY', 'title': 'Range of Motion Change From Baseline Through Week 12 (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'OG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'classes': [{'title': 'Change from Baseline in Range of Motion 12 weeks', 'categories': [{'measurements': [{'value': '1.5', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '14.4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Range of Motion', 'categories': [{'measurements': [{'value': '116.3', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '114.5', 'spread': '16.0', 'groupId': 'OG001'}]}]}, {'title': '12 Week Range of Motion', 'categories': [{'measurements': [{'value': '117.8', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '119.3', 'spread': '15.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1699', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Ordinal GEE Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'Comparison of the change of Range of Motion from baseline through Week 12 between Monovisc and saline arms (ITT Population). Range of motion is defined as the difference between flexion and extension in degrees where full extension range is 180 degrees. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.'}, {'type': 'SECONDARY', 'title': 'WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'OG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'classes': [{'title': 'Change from Baseline in WOMAC Function 12 weeks', 'categories': [{'measurements': [{'value': '-24.1', 'spread': '26.1', 'groupId': 'OG000'}, {'value': '-22.3', 'spread': '25.4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline WOMAC Function', 'categories': [{'measurements': [{'value': '55.8', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '54.1', 'spread': '17.3', 'groupId': 'OG001'}]}]}, {'title': '12 Week WOMAC Function', 'categories': [{'measurements': [{'value': '31.6', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '31.7', 'spread': '25.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3238', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Ordinal GEE Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 Weeks', 'description': 'This endpoint compares the change of the WOMAC Physical Function Score from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. The ITT population includes subjects with data at baseline and 12 Week time points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 12 week time points.'}, {'type': 'POST_HOC', 'title': 'Percentage Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=50% and 20 mm From Baseline Through 26 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'OG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '44.38', 'groupId': 'OG000'}, {'value': '34.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0427', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Ordinal GEE Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '26 Weeks', 'description': 'This post-hoc endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved \\>= a 50% improvement (reduction) in the WOMAC Pain Score and show at least 20 mm improvement (reduction) in the WOMAC Pain Score from baseline through 26 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. Reduction in the WOMAC Pain Score from baseline (e.g. a negative number) indicates improvement in pain. The primary endpoint uses the ITT population that has data available for both baseline and 26 week timepoints.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat population was defined as all randomized patients who received the study injection and had at least one post-injection visit; i.e: at least one visit after the Week 0 visit.'}, {'type': 'POST_HOC', 'title': 'Evaluator Global Assessment Change From Baseline Through Week 26 (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'OG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'classes': [{'title': 'Change from Baseline in Evaluator Global 26 weeks', 'categories': [{'measurements': [{'value': '-27.9', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '-27.5', 'spread': '27.5', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Evaluator Global', 'categories': [{'measurements': [{'value': '59.1', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '58.9', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': '26 Week Evaluator Global', 'categories': [{'measurements': [{'value': '31.9', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '22.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8206', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Ordinal GEE Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '26 Weeks', 'description': 'Comparison of the change of the Evaluator Global Assessment from baseline through Week 26 between Monovisc and saline arms (ITT Population). The Evaluator Global Assessment is done by the Blinded Evaluator, and answers the question "Considering all the ways the osteoarthritis in the patient\'s index knee affect him/her, what is your assessment of how much the patient\'s knee is bothering him/her today?" The Evaluator Global Assessment is scored on a 0 to 100 mm Visual Analog Scale, where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 26 week time points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.'}, {'type': 'POST_HOC', 'title': 'Patient Global Assessment Change From Baseline Through Week 26 (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'OG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'classes': [{'title': 'Change from Baseline in Patient Global 26 weeks', 'categories': [{'measurements': [{'value': '-28.5', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '-28.6', 'spread': '27.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Patient Global', 'categories': [{'measurements': [{'value': '62.9', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': '26 Week Patient Global', 'categories': [{'measurements': [{'value': '33.7', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '26.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9818', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Ordinal GEE Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '26 Weeks', 'description': 'Comparison of the change of the Patient Global Assessment from baseline through Week 26 between Monovisc and saline arms (ITT Population). The Patient Global Assessment is done by the patient, and answers the question "Considering all the ways the osteoarthritis in your study knee affects you, what is your assessment of how much your study knee is bothering you today?" The Patient Global Assessment is scored on a 0 to 100 mm Visual analog Scale, where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 26 week time points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.'}, {'type': 'POST_HOC', 'title': 'Range of Motion Change From Baseline Through Week 26 (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'OG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'classes': [{'title': 'Change from Baseline in Range of Motion 26 Weeks', 'categories': [{'measurements': [{'value': '1.0', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Range of Motion', 'categories': [{'measurements': [{'value': '116.3', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '114.5', 'spread': '16.0', 'groupId': 'OG001'}]}]}, {'title': '26 Week Range of Motion', 'categories': [{'measurements': [{'value': '117.2', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '118.8', 'spread': '14.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0542', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Ordinal GEE Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '26 Weeks', 'description': 'Comparison of the change of Range of Motion from baseline through Week 26 between Monovisc and saline arms (ITT Population). Range of motion is defined as the difference between flexion and extension in degrees where full extension range is 180 degrees. The endpoint uses the ITT population that has data available for both baseline and 26 week time points.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.'}, {'type': 'POST_HOC', 'title': 'WOMAC Physical Function Score Change From Baseline Through Week 26 (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'OG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'classes': [{'title': 'Change from Baseline in WOMAC Function 26 weeks', 'categories': [{'measurements': [{'value': '-23.3', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '-21.4', 'spread': '24.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline WOMAC Function', 'categories': [{'measurements': [{'value': '55.8', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '54.1', 'spread': '17.3', 'groupId': 'OG001'}]}]}, {'title': '26 Week WOMAC Function', 'categories': [{'measurements': [{'value': '32.5', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '25.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3230', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Ordinal GEE Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '26 Weeks', 'description': 'This endpoint compares the change of the WOMAC Physical Function Score from baseline through Week 26 between Monovisc and saline arms (ITT Population). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. The ITT population includes subjects with data at baseline and 26 Week time points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population includes all subjects who received a study injection and who had data for both baseline and 26 week time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'FG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'Intend-to-treat ITT', 'achievements': [{'comment': '3 of 184 excluded from ITT group for not having at least 1 post-injection visit. ITT=181 subjects', 'groupId': 'FG000', 'numSubjects': '181'}, {'comment': '1 of 185 excluded from ITT group for not having at least 1 post-injection visit. ITT=184 subjects', 'groupId': 'FG001', 'numSubjects': '184'}]}, {'type': 'COMPLETED', 'comment': 'Completed through 26 weeks follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Use/Need of Con Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other - Reason Not Provided', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel\n\nMonovisc®: Intra-articular injection'}, {'id': 'BG001', 'title': 'Saline', 'description': '0.9% Sterile Saline\n\nSaline: 0.9% Sterile Saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to Treat Population'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-21', 'studyFirstSubmitDate': '2008-03-05', 'resultsFirstSubmitDate': '2017-09-15', 'studyFirstSubmitQcDate': '2008-04-02', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-14', 'studyFirstPostDateStruct': {'date': '2008-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score (ITT) >=40% and 15 mm From Baseline Through 12 Weeks', 'timeFrame': '12 Weeks', 'description': 'The primary endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved \\>= a 40% improvement (reduction) in the WOMAC Pain Score and show at least 15 mm improvement (reduction) in the WOMAC Pain Score from baseline through 12 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. The primary endpoint uses the ITT population that has data available for both baseline and 12 week time points.'}], 'secondaryOutcomes': [{'measure': 'Evaluator Global Assessment Change From Baseline Through Week 12 (ITT)', 'timeFrame': '12 Weeks', 'description': 'Comparison of the change of the Evaluator Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Evaluator Global Assessment is done by the Blinded Evaluator, and answers the question "Considering all the ways the osteoarthritis in the patient\'s index knee affect him/her, what is your assessment of how much the patient\'s knee is bothering him/her today?" The Evaluator Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS Scale), where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.'}, {'measure': 'Patient Global Assessment Change From Baseline Through Week 12 (ITT)', 'timeFrame': '12 Weeks', 'description': 'Comparison of the change of the Patient Global Assessment from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Patient Global Assessment is done by the patient, and answers the question "Considering all the ways the osteoarthritis in your study knee affects you, what is your assessment of how much your study knee is bothering you today?" The Patient Global Assessment is scored on a 0 to 100 mm Visual Analog Scale (VAS Scale), where a higher number means the patient is bothered to a higher degree. A negative number for the change from baseline indicates a reduction (improvement) in the assessment. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.'}, {'measure': 'Range of Motion Change From Baseline Through Week 12 (ITT)', 'timeFrame': '12 Weeks', 'description': 'Comparison of the change of Range of Motion from baseline through Week 12 between Monovisc and saline arms (ITT Population). Range of motion is defined as the difference between flexion and extension in degrees where full extension range is 180 degrees. The endpoint uses the ITT population that has data available for both baseline and 12 week time points.'}, {'measure': 'WOMAC Physical Function Score Change From Baseline Through Week 12 (ITT)', 'timeFrame': '12 Weeks', 'description': 'This endpoint compares the change of the WOMAC Physical Function Score from baseline through Week 12 between Monovisc and saline arms (ITT Population). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher degree of functional limitation. A negative number for the change from baseline indicates improvement in physical function. The ITT population includes subjects with data at baseline and 12 Week time points.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Monovisc®', 'Hyaluronic Acid Gel', 'Injection', 'Knee'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intra-articular injection of Monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.', 'detailedDescription': 'This randomized, double-blind, placebo controlled prospective study will assess the safety and effectiveness of a single intra-articular injection of Monovisc® in providing symptomatic relief of pain caused by idiopathic osteoarthritis (OA) of the knee as compared to a placebo comparator injection of sterile saline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Male or Female\n* Age 35 to 75 years\n* Body Mass Index (BMI) 20 to 40 kg/m2\n* Willing and able to provide informed consent\n* Willing to limit analgesic use to acetaminophen 7 days prior to and 12 weeks after injection\n* Not pregnant or lactating\n* Previous conservative treatment regimen for osteoarthritis (OA)\n* Diagnosis of idiopathic OA of the index knee\n* OA symptoms for \\>= 6 months\n* Index knee Kellgren-Lawrence (K-L) grade of II or III\n* Index knee Baseline Summed WOMAC Pain Score \\>= 200mm and \\< 400mm after NSAID washout\n* Contralateral Knee K-L grade 0, I or II\n* Contralateral Knee Baseline WOMAC Pain Score \\< 150mm after NSAID washout\n\nMain Exclusion Criteria:\n\n* Joint disorders which could interfere with treatment effectiveness\n* Joint disorders which could interfere with study assessments\n* Arthroscopy of either knee within 3 months of screening\n* Open surgery of index knee within 12 months of screening\n* Open surgery of contralateral knee within 3 months of screening\n* Injection of Hyaluronic Acid (HA) in either knee within 6 months of screening\n* Injection of steroid in index knee within 3 months of screening\n* Any pre-treatment contraindication for injection or aspiration of the index knee, including cutaneous infection, intra-articular infection, knee deformity or condition which may jeopardize sterility or delivery of injection\n* Synovial fluid aspirate volume \\> 20 milliliters (mL)\n* Visual appearance of synovial fluid that contraindicates injection\n* Index knee range of motion \\< 90 degrees\n* Subject participation in other research study within 30 days of screening\n* Subject unwilling to maintain active lifestyle, exercise program and body weight similar to that during 3 months prior to screening for duration of study\n* Unwilling to maintain constant dosage of oral glucosamine or chondroitin sulfate for duration of study, if applicable\n* Other medication or treatments that could interfere with study injection or assessments\n* Allergy to gram positive bacterial products or intolerance of acetaminophen\n* Active fibromyalgia\n* Peripheral neuropathy severe enough to interfere with evaluation of either knee\n* Vascular insufficiency severe enough to interfere with evaluation of the subject\n* Hemiparesis involving either lower extremity\n* Systemic bleeding disorder\n* Other conditions which may adversely affect the success of the procedure'}, 'identificationModule': {'nctId': 'NCT00653432', 'briefTitle': 'Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anika Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate to Provide Symptomatic Relief of Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'Monovisc-0702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monovisc®', 'description': 'Injectable Hyaluronic Acid Gel', 'interventionNames': ['Device: Monovisc®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': '0.9% Sterile Saline', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Monovisc®', 'type': 'DEVICE', 'otherNames': ['Sodium Hyaluronate', 'Hyaluronic Acid Gel'], 'description': 'Intra-articular injection', 'armGroupLabels': ['Monovisc®']}, {'name': 'Saline', 'type': 'OTHER', 'description': '0.9% Sterile Saline', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Consultants', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novara Clinical Research', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tuscon Orthopaedic Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Research', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Arthritis Medical Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80013', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Summit Clinical Research', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Medical Center', 'geoPoint': 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'United States', 'facility': 'Intermountain Research Center', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60053', 'city': 'Morton Grove', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Bone & Joint Institute', 'geoPoint': {'lat': 42.04059, 'lon': -87.78256}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Wellborn Clinic', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'David Neustadt PSC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Rheumatology and Bone Research', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Great Lakes Research Group', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Western Montana Clinic', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Physician Research Collaboration', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Arthritis Center of Reno', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Arthritis, Rheumatic & Back Disease Associates', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '15901', 'city': 'Johnstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Brian Gunnlaugson, MD', 'geoPoint': {'lat': 40.32674, 'lon': -78.92197}}, {'zip': '19152', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Arthritis Group', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19611', 'city': 'West Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research Center of Reading', 'geoPoint': {'lat': 40.3337, 'lon': -75.94743}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'SCRI', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '78550', 'city': 'Harlingen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Orthopedic Clinic', 'geoPoint': {'lat': 26.19063, 'lon': -97.6961}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Stephen Schmitz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Prometrika, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anika Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}