Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00450112
Status:
COMPLETED
Last Update Posted:
2011-08-22
First Post:
2007-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hiroyuki.hosokawa@seikagaku.co.jp', 'phone': '81-3-5220-8950', 'title': 'Clinical Development Dept.', 'organization': 'Seikagaku Corporation'}, 'certainAgreement': {'otherDetails': 'SKK has the right to review the disclosures. Investigator shall not make any publication of study data, results or similar information without the express of permission of SKK.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.', 'otherNumAtRisk': 125, 'otherNumAffected': 44, 'seriousNumAtRisk': 125, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.', 'otherNumAtRisk': 74, 'otherNumAffected': 27, 'seriousNumAtRisk': 74, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 24, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'OG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.1', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '13 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'OG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'spread': '22.68', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '22.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed WOMAC pain subscore on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. Improved score from baseline to week 13 were calculated as baseline minus week 13.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.'}, {'type': 'SECONDARY', 'title': 'Improvement From Baseline in WOMAC VAS (Stiffness Subscore)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'OG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'spread': '24.95', 'groupId': 'OG000'}, {'value': '34.5', 'spread': '25.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Improved score from baseline to week 13 were calculated as baseline minus week 13.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.'}, {'type': 'SECONDARY', 'title': 'Improvement From Baseline in WOMAC VAS (Physical Function Subscore)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'OG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'spread': '22.85', 'groupId': 'OG000'}, {'value': '34.4', 'spread': '24.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Improved score from baseline to week 13 were calculated as baseline minus week 13.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.'}, {'type': 'SECONDARY', 'title': 'Improvement From Baseline in WOMAC VAS (Total Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'OG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'spread': '22.60', 'groupId': 'OG000'}, {'value': '34.6', 'spread': '23.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed..', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.'}, {'type': 'SECONDARY', 'title': 'Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'OG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}], 'classes': [{'title': 'Participants who met strict responders at week 13', 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000'}, {'value': '57.7', 'groupId': 'OG001'}]}]}, {'title': 'Participants who met responders at week 13', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '77.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 13', 'description': 'Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by improvements from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.'}, {'type': 'SECONDARY', 'title': 'Improvement From Baseline in Subject Global Evaluations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'OG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '30.76', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '26.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.'}, {'type': 'SECONDARY', 'title': 'Improvement From Baseline in Physician Global Evaluations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'OG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'spread': '25.08', 'groupId': 'OG000'}, {'value': '27.4', 'spread': '27.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'ciPctValue': '95', 'groupDescription': 'One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.'}, {'type': 'SECONDARY', 'title': 'Acetaminophen Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'OG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}], 'classes': [{'categories': [{'measurements': [{'value': '1677.4', 'spread': '3135.80', 'groupId': 'OG000'}, {'value': '1822.5', 'spread': '2768.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 9 to Week 13', 'description': 'Weekly mean acetaminophen consumption between weeks 9 and 13.', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population was used for analysis. 3 patients with 2Gel-200 were removed from ITT population analysis and baseline because of no post treatment data according to a pre-specified rule. These data were submitted to FDA.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'FG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'Received Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'Analyzed Participants', 'achievements': [{'comment': '3 subjects removed from ITT analyses because of no post treatment data (pre-defined criteria).', 'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Other Treatment Required', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Others', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 202 patients were entered.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '2Gel-200', 'description': 'Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.'}, {'id': 'BG001', 'title': '1PBS1Gel-200', 'description': 'Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '10.29', 'groupId': 'BG000'}, {'value': '61.6', 'spread': '10.50', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '10.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '4.14', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '4.01', 'groupId': 'BG001'}, {'value': '28.8', 'spread': '4.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms/meters square', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC VAS Pain Subscore', 'classes': [{'categories': [{'measurements': [{'value': '69.4', 'spread': '15.82', 'groupId': 'BG000'}, {'value': '69.9', 'spread': '15.13', 'groupId': 'BG001'}, {'value': '69.5', 'spread': '15.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Assessed Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) pain subscores on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC VAS Stiffness Subscore', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '18.31', 'groupId': 'BG000'}, {'value': '70.7', 'spread': '18.40', 'groupId': 'BG001'}, {'value': '70.1', 'spread': '18.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Assessed Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) stiffness subscores on VAS of 100 mm.; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC VAS Physical Function Subcore', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'spread': '17.96', 'groupId': 'BG000'}, {'value': '69.9', 'spread': '16.35', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '17.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Assessed Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) physical function subscores on VAS of 100 mm.; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WOMAC VAS Total Score', 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '17.07', 'groupId': 'BG000'}, {'value': '69.9', 'spread': '15.79', 'groupId': 'BG001'}, {'value': '69.0', 'spread': '16.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) pain, stiffness and physical function subscores on VAS of 100 mm.; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subject Global Evaluations', 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '21.81', 'groupId': 'BG000'}, {'value': '68.2', 'spread': '18.85', 'groupId': 'BG001'}, {'value': '66.9', 'spread': '20.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm.; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physician Global Evaluations', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '16.85', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '20.51', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '18.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm.; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'dispFirstSubmitDate': '2010-06-28', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-25', 'studyFirstSubmitDate': '2007-03-20', 'dispFirstSubmitQcDate': '2010-06-28', 'resultsFirstSubmitDate': '2011-04-15', 'studyFirstSubmitQcDate': '2007-03-20', 'dispFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-25', 'studyFirstPostDateStruct': {'date': '2007-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200', 'timeFrame': '13 weeks'}], 'secondaryOutcomes': [{'measure': 'Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed WOMAC pain subscore on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. Improved score from baseline to week 13 were calculated as baseline minus week 13.'}, {'measure': 'Improvement From Baseline in WOMAC VAS (Stiffness Subscore)', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Improved score from baseline to week 13 were calculated as baseline minus week 13.'}, {'measure': 'Improvement From Baseline in WOMAC VAS (Physical Function Subscore)', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Improved score from baseline to week 13 were calculated as baseline minus week 13.'}, {'measure': 'Improvement From Baseline in WOMAC VAS (Total Score)', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13.'}, {'measure': 'Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response', 'timeFrame': 'Weeks 13', 'description': 'Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by improvements from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).'}, {'measure': 'Improvement From Baseline in Subject Global Evaluations', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.'}, {'measure': 'Improvement From Baseline in Physician Global Evaluations', 'timeFrame': 'Baseline and Week 13', 'description': 'Observed physician evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Improved score from baseline to week 13 were calculated as baseline minus week 13.'}, {'measure': 'Acetaminophen Consumption', 'timeFrame': 'Week 9 to Week 13', 'description': 'Weekly mean acetaminophen consumption between weeks 9 and 13.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'references': [{'pmid': '29780263', 'type': 'DERIVED', 'citation': 'Takamura J, Seo T, Strand V. A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2018 May 9;11:1179544118773068. doi: 10.1177/1179544118773068. eCollection 2018.'}, {'pmid': '27250845', 'type': 'DERIVED', 'citation': 'Strand V, Lim S, Takamura J. Evidence for safety of retreatment with a single intra-articular injection of Gel-200 for treatment of osteoarthritis of the knee from the double-blind pivotal and open-label retreatment clinical trials. BMC Musculoskelet Disord. 2016 Jun 1;17:240. doi: 10.1186/s12891-016-1101-0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a single or repeat intra-articular injection of Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous participation in study SI-6606/01.\n\nExclusion Criteria:\n\n* Female subjects who are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT00450112', 'briefTitle': 'Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seikagaku Corporation'}, 'officialTitle': 'A Multi-Center Extension and Open-Label Study of a Single or Repeat Intra-Articular Injection of Gel-200 in Osteoarthritis of the Knee.', 'orgStudyIdInfo': {'id': 'Gel/1132'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gel-200', 'type': 'DEVICE', 'description': 'Single Intra-articular Injection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'SKK', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seikagaku Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Osamu Akahane', 'oldOrganization': 'Seikagaku Corporation'}}}}