Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-30 @ 7:08 AM
Study NCT ID:
NCT05829850
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2023-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2023-04-13', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety and tolerability of SYNOLIS VA 40/80 assessed with adverse events monitoring throughout the study duration', 'timeFrame': '168 days'}], 'primaryOutcomes': [{'measure': 'Difference in total Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit.', 'timeFrame': '168 days', 'description': 'The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)'}], 'secondaryOutcomes': [{'measure': 'Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis (WOMAC) pain severity index, as compared to D0', 'timeFrame': 'up to 168 days', 'description': 'The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)'}, {'measure': 'Change in the Western Ontario and McMaster Universities Arthritis (WOMAC) functional severity index, as compared to D0', 'timeFrame': 'up to 168 days', 'description': 'The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)'}, {'measure': 'Change in the Western Ontario and McMaster Universities Arthritis (WOMAC) stiffness severity index, as compared to D0', 'timeFrame': 'up to 168 days', 'description': 'The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)'}, {'measure': 'Pain at walking on a 100 mm VAS', 'timeFrame': 'up to 168 days'}, {'measure': 'Percentage of subjects using analgesics', 'timeFrame': 'up to 168 days', 'description': 'New NSAID / analgesics drugs usage'}, {'measure': 'Measurement of relief satisfaction by the patient', 'timeFrame': '168 days', 'description': '7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)'}, {'measure': 'Measurement of therapeutic efficacy by the investigator (assessor)', 'timeFrame': '168 days', 'description': '7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Knee Osteoarthritis', 'Hyaluronic acid'], 'conditions': ['Osteo Arthritis Knee']}, 'descriptionModule': {'briefSummary': 'Multicentre, independent assessment study on SYNOLIS VA 40/80 over a period of 24 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient between 35 and 75 years old\n* Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification:\n\n * Knee pain\n * Positive radiography (presence of osteophytes)\n * Morning stiffness \\< 30 min and/or crepitus while walking\n* Symptoms related to knee osteoarthritis for at least 6 months\n* Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids\n* Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography)\n* VAS pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated\n* Contralateral knee pain \\< 10 mm (VAS) compared to treated knee\n* Patient signed inform consent form\n\nExclusion Criteria:\n\n* Inability to understand the study or language used to be informed/sign the consent\n* Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial\n* Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion\n* Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion\n* Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion\n* Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion\n* Rheumatoid arthritis, joint condition or any other inflammation and arthritis\n* Lupus\n* Dermatological disorder or any epidermal conditions that prevent an intraarticular injection\n* Visible remarkable joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella\n* Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee\n* Osteonecrosis (1 or both knees)\n* Daily dosage \\> 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose \\< 101 mg, must be maintained during the study\n* Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA\n* Fibromyalgia\n* Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study\n* Excessive and repeated consumption of alcohol or illicit substances\n* Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)'}, 'identificationModule': {'nctId': 'NCT05829850', 'briefTitle': 'An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aptissen SA'}, 'officialTitle': 'An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'PMCF2ML Multishot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SYNOLIS VA 40/80', 'description': 'SYNOLIS VA 40/80 (hyaluronic acid 40 mg, sorbitol 80 mg), intra-articular injection', 'interventionNames': ['Device: SYNOLIS VA 40/80']}], 'interventions': [{'name': 'SYNOLIS VA 40/80', 'type': 'DEVICE', 'description': 'Three 2mL injections of SYNOLIS VA 40/80, one week apart', 'armGroupLabels': ['SYNOLIS VA 40/80']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09-038', 'city': 'Lodz', 'country': 'Poland', 'facility': 'SPORTO oddzial na ulicy Miedzianej', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '91-603', 'city': 'Lodz', 'country': 'Poland', 'facility': 'SPORTO oddzial na ulicy Książka (2nd site location)', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '02-757', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Carolina Medical Center', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aptissen SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Noblewell', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}