Osteoarthritis
Conditions
Brief summary
The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an improvement in pain levels and range of motion.
Detailed description
To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.
Interventions
DRUGEUFLEXXA
2.5 mL of EUFLEXXA (per injection) x 3 injections
Sponsors
Ferring Pharmaceuticals
Georgia Institute for Clinical Research, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Be age 30 to 79 2. Give written informed consent for trial participation 3. Must have shoulder pain for a minimum of 6 months but less than 5 years 4. Must have a Pain Intensity Score of \> 5 5. Must be willing to discontinue all pain medications 24 hours prior to each clinic visit 6. Must have a stable pain medication regime 1 month prior to treatment 7. Agrees to maintain pain medication doses within 30% (increase or decrease) of the Baseline dose
Exclusion criteria
1. Any history of full thickness rotator cuff tear or joint effusion 2. A diagnosis of chronic acromioclavical disease, active epicondylitis, or active Carpal Tunnel Disease 3. Has had more than 2 corticosteroid injections in the previous 3 months 4. Has an infection or an inflammatory condition of the trial shoulder 5. Has acute or inflammatory arthropathy in the trial shoulder, e.g. gouty arthritis, psoriatic arthritis or rheumatoid arthritis. Has a history of systemic inflammatory arthropathies, e.g. polyarthritis, rheumatoid arthritis, psoriatic arthritis or gout 6. Has severe joint effusion of the trial shoulder 7. Has a diagnosis of cancer within the past 5 years (basal cell carcinoma is not excluded) 8. Has had any hyaluronate agent or other chondroprotective agents in the trial shoulder 9. Has a hypersensitivity to HA products, eggs, birds or feathers 10. Has a history of substance abuse, alcohol abuse or psychiatric condition, that in the opinion of the Investigator, will potentially interfere with participation 11. Has any medical condition that may increase the risk associated with intra-articular injections, to include (but are not limited to): thrombocytopenia, blood disorders treated with warfarin or anticoagulants, anemia or other concomitant diseases that, in the opinion of the Investigator, will interfere with the evaluation of the trial treatment, e.g., renal or liver disease, uncontrolled diabetes, significant cardiovascular, immune deficiency, or infectious disease 12. Is actively involved in a litigation involving Workers' Compensation 13. Is a female that is pregnant, planning to become pregnant or is lactating 14. Has participated in a clinical trial within the past four weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Reduction in Pain by the Scores. | 6 months | Greater than 50 percent reduction in pain scores from baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EUFLEXXA ACTIVE CONTROL | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | EUFLEXXA |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age Continuous | 59.1 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Number of Participants With a Reduction in Pain by the Scores.
Greater than 50 percent reduction in pain scores from baseline.
Time frame: 6 months
Population: 
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EUFLEXXA | Number of Participants With a Reduction in Pain by the Scores. | 25 participants |