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This clinical trial is to determine the safety and effectiveness of three injections of SUPARTZ (sodium hyaluronate) compared with phosphate buffered saline (PBS) for the treatment of glenohumeral osteoarthritis of the shoulder. The trial contains two phases. Phase I is 26 weeks, double blinded, and subjects are randomized to either SUPARTZ or PBS treatment. Phase II is 26 weeks (total 52 weeks) and open-label so all subjects will receive SUPARTZ injections only.
Phase 3 Study: Multi-center, randomized, double blinded, two phase study to determine the safety and efficacy of 3 injections of SUPARTZ for Osteoarthritis of the Shoulder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supartz | Active Comparator | SUPARTZ® 3 injections over 2 weeks |
|
| Phosphate Buffered Saline | Placebo Comparator | Phosphate Buffered Saline 3 injections over 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUPARTZ® | Device | Three Supartz injections over 2 weeks into the glenohumeral joint space. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS: 0-100) for Pain on Movement | Visual Analogue Scale (VAS) for pain on (shoulder) movement with a range of 0 to100; where 0=No pain at all and 100=Pain as bad as it can be. Q: How bad is the pain in your study shoulder with activity or movement? (For example, when putting on a coat, sleeping on your study shoulder side, combing your hair, reaching a high shelf, etc.) Reported is a single Least square mean point estimate over the 7-26 week time interval using the assessments collected at weeks 7, 13, 20, and 26 | Ph1: weeks 7 - 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Sledge, MD | Northeast Orthopedics - Unlimited Research | Principal Investigator |
| Charles Birbara, MD | Clinical Pharmacology Study Group | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ph1: Supartz (Double Blind) | SUPARTZ® 3 injections over 2 weeks SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space. |
| FG001 | Ph1: Phosphate Buffered Saline (Double Blind) | Phosphate Buffered Saline 3 injections over 2 weeks Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space. |
| FG002 | Ph2: Supartz (Open Label) | SUPARTZ® 3 injections over 2 weeks SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ph 1: Blinded, Randomized, Controlled |
|
| |||||||||||||||||||||
| Ph 2: Open Label, Single (Supartz) Arm |
|
Double Blind = Intention-to-treat (ITT): all subjects randomized Open Label = Retreatment Subjects, All ITT subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Ph1: Supartz (Double Blind) | SUPARTZ® 3 injections over 2 weeks SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space. |
| BG001 | Ph1: Phosphate Buffered Saline (Double Blind) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Scale (VAS: 0-100) for Pain on Movement | Visual Analogue Scale (VAS) for pain on (shoulder) movement with a range of 0 to100; where 0=No pain at all and 100=Pain as bad as it can be. Q: How bad is the pain in your study shoulder with activity or movement? (For example, when putting on a coat, sleeping on your study shoulder side, combing your hair, reaching a high shelf, etc.) Reported is a single Least square mean point estimate over the 7-26 week time interval using the assessments collected at weeks 7, 13, 20, and 26 | Glenohumeral Osteoarthritis (GH-OA) Intention-to-Treat (ITT) population includes all randomized subjects who had no clinical diagnosis of concomitant pathologies in the trial shoulder | Posted | Least Squares Mean | Standard Error | units on a scale | Ph1: weeks 7 - 26 |
|
52 weeks: Ph1 (Double Blind) from baseline week 0 to week 26 (26 weeks); Ph2 (Open Label) week 26 to week 52 (26 weeks)
This study had 2 phases. Phase 1 was double blind for 26 weeks. Phase 2 was an open label extension for 26 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supartz (Double Blind) | SUPARTZ® 3 injections over 2 weeks SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory and Clinical Affairs | Bioventus LLC | 18003964325 | CT.gov@bioventusglobal.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Phosphate Buffered Saline |
| Device |
Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space. |
|
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
Phosphate Buffered Saline 3 injections over 2 weeks
Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Ph1: Phosphate Buffered Saline (Double Blind) | Phosphate Buffered Saline 3 injections over 2 weeks Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space. |
|
|
|
| 11 |
| 150 |
| 54 |
| 150 |
| EG001 | Phosphate Buffered Saline (Double Blind) | Phosphate Buffered Saline 3 injections over 2 weeks Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space. | 5 | 150 | 56 | 150 |
| EG002 | Supartz (Open Label) | SUPARTZ® 3 injections over 2 weeks SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space. | 5 | 224 | 21 | 224 |
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
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| Bone fragmentation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Patella fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Tendon injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
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