Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-12 @ 10:38 PM
Study NCT ID:
NCT02610504
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Single Center Open Label Study of Shoulder OA Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-20', 'size': 1004246, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-11-07T16:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder pain on movement (SPOM) 0-100mm VAS', 'timeFrame': 'over 26 weeks'}], 'secondaryOutcomes': [{'measure': 'Shoulder pain at night (SPAN) 0-100mm VAS', 'timeFrame': 'over 26 weeks'}, {'measure': 'American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form', 'timeFrame': 'over 26 weeks'}, {'measure': 'Patient Global Assessment (PGA)', 'timeFrame': 'over 26 weeks'}, {'measure': 'Shoulder pain rescue medication diary', 'timeFrame': 'over 26 weeks'}, {'measure': 'Adverse events, concomitant medications, physical exam', 'timeFrame': 'over 26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['degenerative arthritis'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients', 'detailedDescription': 'Subjects 19-85 years old will receive a single intra-articular (IA) injection of DUROLANE® 3mL given for the relief of pain in the treatment of symptomatic osteoarthritis (OA) of the shoulder followed over a 26-week time period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of glenohumeral osteoarthritis\n* SPOM score greater than or equal to 50 in study shoulder\n* Willing to discontinue oral and topical analgesia other than rescue acetaminophen\n* abstinence from any other IA or per-articular injections for the shoulder during the course of the trial\n* patients with chronic shoulder pain lasting more than 6 months without clinically significant improvement in pain over the past one month\n* pain at least 50% of the days during previous month\n* patients who have failed conventional therapy of NSAIDs or steroid injections\n* patients with a retained active range of motion of at least 30% in all directions to rule out frozen shoulder\n* cooperative and able to communicate effectively\n* agree not to participate in any other studies during trial\n\nExclusion Criteria:\n\n* significant pain from other joints requiring chronic analgesic therapy\n* presence of one or more conditions besides OA that could confound pain and functional assessments\n* clinically apparent tense effusion, malalignment or instability in study shoulder\n* shoulder x-rays of acute fractures, sever loss of bone density, avascular necrosis or severe deformity\n* inability to abstain from analgesic use other than rescue acetaminophen\n* IA injections of steroids to the study shoulder within 3 months or any other joint within the prior month\n* IA injection of hyaluronic acid in the study shoulder within 9 months of baseline\n* allergic reaction to HA\n* any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion or may compromise pain assessments of shoulder\n* uncontrolled hypothyroidism\n* pregnant or breastfeeding women\n* planned surgical procedure\n* history or presence of septic arthritis of study joint or active skin disease or infection in the area of the injection site\n* treatment with glucosamine/chondroitin initiated or unstable within 3 months of baseline or change in physical therapy for the study shoulder within 1 month of baseline'}, 'identificationModule': {'nctId': 'NCT02610504', 'briefTitle': 'Prospective Single Center Open Label Study of Shoulder OA Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioventus LLC'}, 'officialTitle': 'A 26 Week Prospective Open Label Clinical Study Evaluating A Single Intra-Articular Injection of Durolane 3ml for Treatment of Osteoarthritis Pain of the Shoulder', 'orgStudyIdInfo': {'id': '13DUR503'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Durolane 3ml', 'description': 'Single intra-articular injection into shoulder', 'interventionNames': ['Device: Durolane']}], 'interventions': [{'name': 'Durolane', 'type': 'DEVICE', 'otherNames': ['Hyaluronic Acid'], 'description': 'single injection of 3ml', 'armGroupLabels': ['Durolane 3ml']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'St. Michaels Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Michael McKee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Michaels Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioventus LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}