Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01934218
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2013-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Gel-One Treatment in Knee 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yuko.shibata@seikagaku.co.jp', 'phone': '(81)3-5220-8948', 'title': 'Clinical Development Dept.', 'organization': 'Seikagaku Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '25 months', 'eventGroups': [{'id': 'EG000', 'title': 'Gel-One', 'description': '3 mL, a single intra-articular injection of Gel-One.', 'otherNumAtRisk': 404, 'deathsNumAtRisk': 404, 'otherNumAffected': 107, 'seriousNumAtRisk': 404, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Placebo', 'description': '3 mL, a single intra-articular injection of PBS.', 'otherNumAtRisk': 410, 'deathsNumAtRisk': 410, 'otherNumAffected': 113, 'seriousNumAtRisk': 410, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gel-One', 'description': 'The participants received a single intra-articular injection of Gel-One.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants received a single intra-articular injection of PBS.'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.7', 'groupId': 'OG000', 'lowerLimit': '-33.7', 'upperLimit': '-29.6'}, {'value': '-31.7', 'groupId': 'OG001', 'lowerLimit': '-33.7', 'upperLimit': '-29.6'}]}]}], 'analyses': [{'pValue': '0.988', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '2.7', 'statisticalMethod': 'Basic longitudinal model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week26', 'description': 'Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gel-One', 'description': 'The participants received a single intra-articular injection of Gel-One.'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.5', 'groupId': 'OG000', 'lowerLimit': '-32.1', 'upperLimit': '-26.9'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'groupDescription': 'A post-hoc non-inferiority comparison of the Gel-One mean change from baseline in VAS pain score at week 26 (Following 50-foot walk test) against the same assessment collected from subjects treated with Euflexxa in a separate study (PMID:19539353) was also performed.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Euflexxa would be considered superior to Gel-One if the difference in mean change from baseline in VAS pain score at week 26 was 5 mm or greater (on the 100mm VAS pain scale). If the difference in mean change values were within 5 mm, Gel-One would not be considered inferior to Euflexxa.', 'otherAnalysisDescription': 'Change from baseline (95% CI) for Euflexxa was -25.7 (-29.0, -22.4) and the difference between Euflexxa and Gel-One (95% CI) was -3.8 (-inf, -0.3).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline to week 26 was calculated as baseline minus week 26.', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The post-hoc analysis plan pre-specified that only the change at week 26 in the Gel-One arm is intended to be analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gel-One', 'description': 'The participants received a single intra-articular injection of Gel-One.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'The participants received a single intra-articular injection of Phosphate Buffered Saline (PBS).'}], 'periods': [{'title': 'Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '404'}, {'groupId': 'FG001', 'numSubjects': '410'}]}, {'type': 'Analyzed Participants', 'comment': '5 subjects removed from ITT analyses because of no post treatment data. (Pre-defined)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '402'}, {'groupId': 'FG001', 'numSubjects': '407'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '356'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Noncompliance with Study Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation of Study Eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Open-Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '316'}, {'groupId': 'FG001', 'numSubjects': '328'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}, {'groupId': 'FG001', 'numSubjects': '304'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Noncompliance with Study Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Failure to Exam Primary Evaluation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'BG000'}, {'value': '407', 'groupId': 'BG001'}, {'value': '809', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gel-One', 'description': 'The participants received a single intra-articular injection of Gel-One.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'The participants received a single intra-articular injection of PBS.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '9.14', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '9.32', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '9.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '455', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '367', 'groupId': 'BG000'}, {'value': '379', 'groupId': 'BG001'}, {'value': '746', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '277', 'groupId': 'BG001'}, {'value': '524', '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': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '28.597', 'spread': '4.1923', 'groupId': 'BG000'}, {'value': '28.797', 'spread': '3.9244', 'groupId': 'BG001'}, {'value': '28.698', 'spread': '4.0585', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms / meter square', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Kellgren-Lawrence score', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '260', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The Kellgren-Lawrence score is radiological classification of knee osteoarthritis. It progresses from grade 0 to grade IV and classified based on x-rays.', 'unitOfMeasure': 'participants'}, {'title': 'osteoarthritis knee disease duration', 'classes': [{'categories': [{'measurements': [{'value': '6.80', 'spread': '7.835', 'groupId': 'BG000'}, {'value': '6.90', 'spread': '7.072', 'groupId': 'BG001'}, {'value': '6.85', 'spread': '7.456', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Etiology', 'classes': [{'title': 'Idiopathic', 'categories': [{'measurements': [{'value': '359', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '718', 'groupId': 'BG002'}]}]}, {'title': 'Post-traumatic', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Study knee', 'classes': [{'title': 'Right', 'categories': [{'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '421', 'groupId': 'BG002'}]}]}, {'title': 'Left', 'categories': [{'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': '50-foot walk test VAS pain score', 'classes': [{'categories': [{'measurements': [{'value': '69.25', 'spread': '7.640', 'groupId': 'BG000'}, {'value': '69.36', 'spread': '7.817', 'groupId': 'BG001'}, {'value': '69.31', 'spread': '7.725', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Observed Visual Analogue Scale (VAS) pain score of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme target knee pain following 50-foot walk test.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '50-foot walk test contralateral VAS pain score', 'classes': [{'categories': [{'measurements': [{'value': '11.50', 'spread': '7.536', 'groupId': 'BG000'}, {'value': '11.95', 'spread': '7.565', 'groupId': 'BG001'}, {'value': '11.73', 'spread': '7.549', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Observed VAS pain score of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme contralateral knee pain following 50-foot walk test.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 814}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2013-08-29', 'resultsFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2013-08-29', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-02', 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26', 'timeFrame': 'Baseline up to Week26', 'description': 'Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Knee', 'Osteoarthritis', 'Intra-articular injection'], 'conditions': ['Osteoarthritis Knee']}, 'referencesModule': {'references': [{'pmid': '29644875', 'type': 'DERIVED', 'citation': 'Takamura J, Seo T, Strand V. A Single Intra-Articular Injection of Gel-200 for Treatment of Symptomatic Osteoarthritis of the Knee Is More Effective than Phosphate Buffered Saline at 6 Months: A Subgroup Analysis of a Multicenter, Randomized Controlled Trial. Cartilage. 2019 Oct;10(4):417-422. doi: 10.1177/1947603518768015. Epub 2018 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a knee pain\n* Grade 1 to 3 on the Kellgren-Lawrence grading scale\n\nExclusion Criteria:\n\n* BMI greater than 35 kg/m2\n* Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening\n* Had a joint replacement of the target knee'}, 'identificationModule': {'nctId': 'NCT01934218', 'briefTitle': 'Gel-One Treatment in Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seikagaku Corporation'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, 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