Status:
COMPLETED
Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)
Lead Sponsor:
Georgia Institute for Clinical Research, LLC
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Osteoarthritis
Eligibility:
All Genders
30-79 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Be age 30 to 79
- Give written informed consent for trial participation
- Must have shoulder pain for a minimum of 6 months but less than 5 years
- Must have a Pain Intensity Score of \> 5
- Must be willing to discontinue all pain medications 24 hours prior to each clinic visit
- Must have a stable pain medication regime 1 month prior to treatment
- Agrees to maintain pain medication doses within 30% (increase or decrease) of the Baseline dose
Exclusion
- Any history of full thickness rotator cuff tear or joint effusion
- A diagnosis of chronic acromioclavical disease, active epicondylitis, or active Carpal Tunnel Disease
- Has had more than 2 corticosteroid injections in the previous 3 months
- Has an infection or an inflammatory condition of the trial shoulder
- 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
- Has severe joint effusion of the trial shoulder
- Has a diagnosis of cancer within the past 5 years (basal cell carcinoma is not excluded)
- Has had any hyaluronate agent or other chondroprotective agents in the trial shoulder
- Has a hypersensitivity to HA products, eggs, birds or feathers
- Has a history of substance abuse, alcohol abuse or psychiatric condition, that in the opinion of the Investigator, will potentially interfere with participation
- 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
- Is actively involved in a litigation involving Workers' Compensation
- Is a female that is pregnant, planning to become pregnant or is lactating
- Has participated in a clinical trial within the past four weeks
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00969501
Start Date
August 1 2009
End Date
August 1 2010
Last Update
May 7 2013
Active Locations (1)
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1
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States, 30060