Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-27 @ 11:59 PM
Study NCT ID:
NCT02242435
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2014-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'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': 'clinicaltrials@ampiopharma.com', 'phone': '7204376500', 'title': 'Dr. Howard Levy / Chief Medical Officer', 'organization': 'Ampio Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 Weeks', 'description': 'Patients will be followed for the occurrence of Adverse Events (AEs) from Baseline through Week 24.', 'eventGroups': [{'id': 'EG000', 'title': 'Ampion 4 mL', 'description': '4 mL intra-articular injection of Ampion\n\nAmpion \\<5 kDa ultrafiltrate of 5% human serum albumin: 4 mL intra-articular injection of Ampion', 'otherNumAtRisk': 172, 'deathsNumAtRisk': 172, 'otherNumAffected': 107, 'seriousNumAtRisk': 172, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo 4 mL', 'description': '4 mL placebo intra-articular injection\n\nPlacebo: Saline', 'otherNumAtRisk': 170, 'deathsNumAtRisk': 170, 'otherNumAffected': 125, 'seriousNumAtRisk': 170, 'deathsNumAffected': 1, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Injection Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Respiratory Tract Infection Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Joint Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Joint Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Joint Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Plantar Fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Plasma Cell Myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Salivary Gland Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Incisional Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Joint Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abcess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Knee Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ampion 4 mL Injection', 'description': '4 mL intra-articular injection of Ampion\n\nAmpion: \\<5 kDa ultrafiltrate of 5% human serum albumin'}, {'id': 'OG001', 'title': 'Placebo 4 mL Injection', 'description': '4 mL placebo intra-articular injection\n\nPlacebo: Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.96', 'groupId': 'OG000', 'lowerLimit': '-1.09', 'upperLimit': '-0.82'}, {'value': '-1.10', 'groupId': 'OG001', 'lowerLimit': '-1.24', 'upperLimit': '-0.95'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjusted for baseline WOMAC score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Scored at Baseline and 20 Weeks', 'description': 'Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Change in Knee Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ampion 4 mL Injection', 'description': '4 mL intra-articular injection of Ampion\n\nAmpion: \\<5 kDa ultrafiltrate of 5% human serum albumin'}, {'id': 'OG001', 'title': 'Placebo 4 mL Injection', 'description': '4 mL placebo intra-articular injection\n\nPlacebo: Saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.94', 'groupId': 'OG000', 'lowerLimit': '-1.08', 'upperLimit': '-0.81'}, {'value': '-1.08', 'groupId': 'OG001', 'lowerLimit': '-1.22', 'upperLimit': '-0.94'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjustment for baseline WOMAC score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Scored at Baseline and 20 Weeks', 'description': 'Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ampion 4 mL', 'description': '4 mL intra-articular injection of Ampion\n\nAmpion \\<5 kilodalton (kDa) ultrafiltrate of 5% human serum albumin: 4 mL intra-articular injection of Ampion'}, {'id': 'FG001', 'title': 'Placebo 4 mL', 'description': '4 mL placebo intra-articular injection\n\nPlacebo: Saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '170'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment of subjects occurred in medical clinics during the months of September, October, and November 2014.', 'preAssignmentDetails': 'No pharmacological or non-pharmacological treatment targeting osteoarthritis (OA) started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ampion 4 mL', 'description': '4 mL intra-articular injection of Ampion\n\nAmpion \\<5 kDa ultrafiltrate of 5% human serum albumin'}, {'id': 'BG001', 'title': 'Placebo 4 mL', 'description': '4 mL placebo intra-articular injection\n\nPlacebo: Saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '63.2', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '63.2', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '319', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '96.2', 'spread': '23.8', 'groupId': 'BG000'}, {'value': '96.4', 'spread': '22.5', 'groupId': 'BG001'}, {'value': '96.3', 'spread': '23.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '34.9', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '34.6', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Kellgren-Lawrence (KL) Grade', 'classes': [{'categories': [{'title': 'Kellgren-Lawrence Grade III', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Kellgren-Lawrence Grade IV', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Kellgren-Lawrence grading is based on the radiologic features of osteoarthritis.\n\nAnn Rheum Dis. 1957;16:494-502.\n\nGrade III (Moderate): Moderate osteophytes, definite joint space narrowing, some sclerosis, possible bone-end deformity.\n\nGrade IV (Severe): Large osteophytes, marked joint space narrowing, severe sclerosis, definite bone ends deformity.', 'unitOfMeasure': 'Participants'}, {'title': 'WOMAC Pain', 'classes': [{'categories': [{'measurements': [{'value': '2.51', 'spread': '0.57', 'groupId': 'BG000'}, {'value': '2.57', 'spread': '0.61', 'groupId': 'BG001'}, {'value': '2.54', 'spread': '0.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Western Ontario and McMaster Universities Arthritis Index (WOMAC) 3.1 evaluates Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright.\n\nSubjects respond to each subscale by using a 5-point Likert score. (0=none; 1=mild; 2=moderate; 3=severe; 4=extreme). Mean of the 5 scores constitutes the Baseline Pain Score.\n\nThe minimum score on this scale is 0, and the maximum score is 4. Higher scores are indicative of higher levels of self-reported pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC Function', 'classes': [{'categories': [{'measurements': [{'value': '2.51', 'spread': '0.63', 'groupId': 'BG000'}, {'value': '2.59', 'spread': '0.61', 'groupId': 'BG001'}, {'value': '2.55', 'spread': '0.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'WOMAC 3.1 evaluates Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of bath, sitting, getting on/off toilet, heavy/light domestic duties.\n\nSubjects respond to each by using a 5-point Likert score. (0=none; 1=mild; 2=moderate; 3=severe; 4=extreme). Mean of the 17 scores constitutes the Baseline Function Score. Minimum score is 0; maximum is 4.\n\nHigher scores indicate of higher levels of limitations of self-reported physical function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent to Treat (ITT)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'dispFirstSubmitDate': '2019-06-18', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2014-09-15', 'dispFirstSubmitQcDate': '2019-06-18', 'resultsFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2014-09-16', 'dispFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-04', 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Knee Pain', 'timeFrame': 'Scored at Baseline and 20 Weeks', 'description': 'Mean Change in WOMAC A Pain (Western Ontario and McMaster Universities Arthritis Index) score from Baseline to 12 weeks. 5-point Likert scale (0=none to 4=extreme). A negative difference constitutes a decrease in pain with a greater negative value indicating a greater reduction in pain.'}], 'secondaryOutcomes': [{'measure': 'Change in Knee Function', 'timeFrame': 'Scored at Baseline and 20 Weeks', 'description': 'Mean change in WOMAC C function score (Western Ontario and McMaster Universities Arthritis Index) from Baseline to 12 weeks. 5-point Likert scale indicating limitation of function (0=none to 4=extreme). A greater negative value indicates a improvement in function.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'osteoarthritis of the knee'], 'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy of three intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.', 'detailedDescription': "A randomized, placebo-controlled, double-blinded study to evaluate the efficacy and safety of repeated intra-articular injections of Ampion™ in adult subjects with advanced osteoarthritis of the knee.\n\nThe primary study objective was to evaluate the efficacy and safety from Baseline to Week 20 of 3 Ampion™ 4 mL intra-articular (IA) injections vs saline administered 2 weeks apart in improving knee pain in subjects suffering from osteoarthritis (OA) of the knee (OAK).\n\nThe secondary study objective was to analyze the effect of Ampion 4 mL vs saline on a change in Patient's Global Assessment (PGA) and knee function from Baseline to Week 20."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to provide written informed consent to participate in the study.\n2. Willing and able to comply with all study requirements and instructions of the site study staff.\n3. Male or female, 40 years to 85 years old (inclusive).\n4. Must be ambulatory.\n5. Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (x-ray) acquired at screening and assessed by a central reader. Subjects must have a Kellgren Lawrence Grade of III or IV for inclusion in the study.\n6. Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC® Index 3.1 5-point Likert Pain Subscale) assessed at screening and confirmed at randomization.\n7. Moderate to moderately-severe OA pain in the index knee (even if chronic doses of non-steroidal anti-inflammatory drug \\[NSAID\\], which have not changed in the 4 weeks prior to screening, have been/are being used).\n8. No analgesia taken 24 hours before efficacy measure.\n\nExclusion Criteria:\n\n1. As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.\n2. Previous Ampion™ injection in the index knee.\n3. Known clinically significant liver abnormality (e.g., cirrhosis, transplant, etc).\n4. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion).\n5. A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).\n6. Presence of tense effusions in the index knee.\n7. Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the index knee, as assessed locally by the Principal Investigator.\n8. Isolated patella femoral syndrome, also known as chondromalacia, in the index knee.\n9. Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (e.g., cancer, congenital defects, spine OA).\n10. Major injury to the index knee within the 12 months prior to screening.\n11. Severe hip OA ipsilateral to the index knee.\n12. Any pain that could interfere with the assessment of index knee pain (e.g., pain in any other part of the lower extremities, pain radiating to the knee).\n13. Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to treatment or likely to be changed during the duration of the study.\n14. Use of the following medications are exclusionary:\n\n 1. IA injected pain medications in the study knee during the study;\n 2. Analgesics containing opioids. NSAIDs may be continued at levels preceding the study and acetaminophen is available as a rescue medication during the study from the provided supply;\n 3. Topical treatment on osteoarthritis index knee during the study;\n 4. Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin and Plavix are allowed);\n 5. Systemic treatments that may interfere with safety or efficacy assessments during the study;\n 6. Immunosuppressants;\n 7. Use of corticosteroids \\> 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable).\n15. Any human albumin treatment in the 3 months before randomization.'}, 'identificationModule': {'nctId': 'NCT02242435', 'briefTitle': 'A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ampio Pharmaceuticals. Inc.'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Three Intra-articular Injections of Ampion™ (4 mL) Administered Two Weeks Apart in Adults With Pain Due to Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': 'AP-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ampion 4ml dose', 'description': '4 mL intra-articular injection of Ampion', 'interventionNames': ['Biological: 4 mL injection of Ampion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Solution', 'description': '4 mL placebo intra-articular injection', 'interventionNames': ['Drug: 4 mL Injection of Placebo']}], 'interventions': [{'name': '4 mL injection of Ampion', 'type': 'BIOLOGICAL', 'description': '4 mL injection of Ampion', 'armGroupLabels': ['Ampion 4ml dose']}, {'name': '4 mL Injection of Placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'armGroupLabels': ['Placebo Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80112', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Ampio Pharmaceuticals, Inc.', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}], 'overallOfficials': [{'name': 'Howard Levy, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ampio Pharmaceuticals. Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ampio Pharmaceuticals. Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}