Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)

Investigator Initiated, Exploratory Case Study Three Injections of EUFLEXXA (Sodium Hyaluronate)Treatment of Chronic Shoulder Pain Associated With Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: EUFLEXXA

Detailed Description

To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EUFLEXXA; ACTIVE CONTROL	Drug: EUFLEXXA; 2.5 mL of EUFLEXXA (per injection) x 3 injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Reduction in Pain by the Scores.	Greater than 50 percent reduction in pain scores from baseline.	6 months

Collaborators and Investigators

• Sponsor: Georgia Institute for Clinical Research, LLC
• Collaborators: Ferring Pharmaceuticals
• Investigators: Principal Investigator: Arnold J. Weil, M.D., Georgia Institute for Clinical Research, LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: August 31, 2009
• First Submitted That Met QC Criteria: August 31, 2009
• First Posted (Estimate): September 1, 2009

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: March 27, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Arthralgia; Osteoarthritis; Shoulder Pain
• Other Study ID Numbers: EUF-SHO-0001