Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-30 @ 8:51 PM
Study NCT ID:
NCT01265459
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2010-12-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Different Volumes of Durolane in Knee OA
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': 'reception.SEUPP@galderma.com', 'phone': '+46 (0) 18 4749000', 'title': 'Head of Medical Affairs', 'organization': 'Q-Med AB'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected during 26 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Durolane 3 mL', 'description': 'Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)', 'otherNumAtRisk': 23, 'otherNumAffected': 8, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Durolane 4.5 mL', 'description': 'Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)', 'otherNumAtRisk': 23, 'otherNumAffected': 12, 'seriousNumAtRisk': 23, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Durolane 6 mL', 'description': 'Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)', 'otherNumAtRisk': 22, 'otherNumAffected': 14, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Arthralgia', 'notes': 'The related arthralgia events had a rapid onset and usually started within 1 day after injection of the study product and the duration was in general short.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache and high fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rectal prolaps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Pain Over 26 Weeks (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durolane 3 mL', 'description': 'WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).'}, {'id': 'OG001', 'title': 'Durolane 4.5 mL', 'description': 'WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).'}, {'id': 'OG002', 'title': 'Durolane 6 mL', 'description': 'WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.13', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '-4.00', 'spread': '3.74', 'groupId': 'OG001'}, {'value': '-4.90', 'spread': '5.06', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks after treatment compared to baseline', 'description': 'The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions.\n\nIt is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary population for all efficacy evaluations was the ITT population (all subjects randomized and treated with study product).\n\nNo imputation of missing data was done. Analyses presented were based on observed cases.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durolane 3 mL', 'description': 'Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)'}, {'id': 'OG001', 'title': 'Durolane 4.5 mL', 'description': 'Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)'}, {'id': 'OG002', 'title': 'Durolane 6 mL', 'description': 'Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to 26 weeks after treatment', 'description': 'Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, "Since your last clinical visit have you had any health problems?".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WOMAC Stiffness Score (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durolane 3 mL', 'description': 'WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).'}, {'id': 'OG001', 'title': 'Durolane 4.5 mL', 'description': 'WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).'}, {'id': 'OG002', 'title': 'Durolane 6 mL', 'description': 'WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.30', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '-1.15', 'spread': '1.90', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks after treatment compared to baseline', 'description': 'The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions.\n\nIt is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'WOMAC Physical Function Score (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durolane 3 mL', 'description': 'WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).'}, {'id': 'OG001', 'title': 'Durolane 4.5 mL', 'description': 'WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).'}, {'id': 'OG002', 'title': 'Durolane 6 mL', 'description': 'WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.14', 'spread': '13.98', 'groupId': 'OG000'}, {'value': '-13.13', 'spread': '11.93', 'groupId': 'OG001'}, {'value': '-12.32', 'spread': '14.86', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks after treatment compared to baseline', 'description': 'The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions.\n\nIt is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Durolane 3 mL', 'description': 'Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).\n\nSingle injection of Durolane (20 mg/ml).'}, {'id': 'OG001', 'title': 'Durolane 4.5 mL', 'description': 'Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).\n\nSingle injection of Durolane (20 mg/ml).'}, {'id': 'OG002', 'title': 'Durolane 6 mL', 'description': 'Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).\n\nSingle injection of Durolane (20 mg/ml).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '2.44', 'groupId': 'OG001'}, {'value': '1.70', 'spread': '3.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '26 weeks after treatment compared to baseline', 'description': 'The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale, Subject global assessment scale, from "very poor=0" to "excellent=10".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Durolane 3 mL', 'description': 'Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)'}, {'id': 'FG001', 'title': 'Durolane 4.5 mL', 'description': 'Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)'}, {'id': 'FG002', 'title': 'Durolane 6 mL', 'description': 'Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Durolane 3 mL', 'description': 'Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)'}, {'id': 'BG001', 'title': 'Durolane 4.5 mL', 'description': 'Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)'}, {'id': 'BG002', 'title': 'Durolane 6 mL', 'description': 'Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '7.3', 'groupId': 'BG002'}, {'value': '63.1', 'spread': '8.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-24', 'studyFirstSubmitDate': '2010-12-17', 'resultsFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2010-12-22', 'lastUpdatePostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-03', 'studyFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Pain Over 26 Weeks (Change From Baseline)', 'timeFrame': '26 weeks after treatment compared to baseline', 'description': 'The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions.\n\nIt is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.', 'timeFrame': 'From baseline to 26 weeks after treatment', 'description': 'Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, "Since your last clinical visit have you had any health problems?".'}, {'measure': 'WOMAC Stiffness Score (Change From Baseline)', 'timeFrame': '26 weeks after treatment compared to baseline', 'description': 'The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions.\n\nIt is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.'}, {'measure': 'WOMAC Physical Function Score (Change From Baseline)', 'timeFrame': '26 weeks after treatment compared to baseline', 'description': 'The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions.\n\nIt is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question.'}, {'measure': 'Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)', 'timeFrame': '26 weeks after treatment compared to baseline', 'description': 'The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale, Subject global assessment scale, from "very poor=0" to "excellent=10".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.', 'detailedDescription': 'To assess the safety and efficacy profiles of different volumes of Durolane in patients with knee OA and compare with the current standard single-injection of the product. The study aims to investigate whether different volumes of Durolane compared to the standard injection volume will improve the benefit/risk profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject (female or male)\n* 40-85 years of age\n* Unilateral knee pain fulfilling American College of Rheumatology (ACR) criteria for diagnosis of osteoarthritis(OA)\n* Radiographic evidence of OA in the study knee\n* WOMAC pain score of 7-17 in the study knee\n* WOMAC pain score of 2-3 in the study knee (WOMAC Likert 3.1 A1)\n* Subject normally active\n* Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies)and to simple analgetics\n* Subject cooperative and able to communicate effectively with the investigators\n* Body mass index ≤ 35 kg/m2;\n* Signed informed consent obtained\n\nExclusion Criteria:\n\n* Knee effusion\n* Contralateral knee OA\n* Clinically significant joint pain from joints other than the knee\n* Previous intra-articular steroid injection into the study knee within the last 6 months\n* Previous intra-articular Hyaluronic Acid (HA) injection into the study knee within the last 9 months\n* Previous allergic type reaction to a HA product\n* Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit\n* Use of analgesics 48 hours preceding the baseline visit\n* Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months\n* Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months\n* Change in physical therapy for the knee within the last three months\n* Arthroscopy or other surgical procedure in the study knee within the past 12 months\n* Serious injuries to the study knee in the past\n* Any planned arthroscopy or other surgical procedure during the study period\n* Previous history or presence of active septic arthritis\n* Active skin disease or infection in the area of the injection site\n* Systemic active inflammatory condition or infection\n* Bleeding diathesis or use of anticoagulants\n* History of drug or alcohol abuse within 6 months\n* Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion\n* Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception\n* Involvement in other clinical trials'}, 'identificationModule': {'nctId': 'NCT01265459', 'briefTitle': 'Different Volumes of Durolane in Knee OA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': '35GA1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Durolane 3ml', 'description': 'Durolane 3 ml is an Intraarticular hyaluronic acid', 'interventionNames': ['Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml']}, {'type': 'EXPERIMENTAL', 'label': 'Durolane 4.5', 'description': 'Durolane 4.5 is an Intraarticular hyaluronic acid', 'interventionNames': ['Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml']}, {'type': 'EXPERIMENTAL', 'label': 'Durolane 6 ml', 'description': 'Durolane 6 ml is an Intraarticular hyaluronic acid', 'interventionNames': ['Device: Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml']}], 'interventions': [{'name': 'Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml', 'type': 'DEVICE', 'description': 'Durolane is an intraarticular hyaluronic acid preparation', 'armGroupLabels': ['Durolane 3ml', 'Durolane 4.5', 'Durolane 6 ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '211 36', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Torsten Adalberth', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '111 35', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Christian Akermark', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '194 89', 'city': 'Upplands Vasby', 'country': 'Sweden', 'facility': 'Johan Isacson', 'geoPoint': {'lat': 59.51839, 'lon': 17.91128}}], 'overallOfficials': [{'name': 'Per-Erik Melberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kristinelundskliniken, Kristinelundsgatan 13, 411 37 Göteborg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}