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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969501
• Other study ID #: EUF-SHO-0001
• Status: Completed
• Phase: N/A
• First received: August 31, 2009
• Last updated: March 27, 2013
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: March 2013
• Source: Georgia Institute for Clinical Research, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 79 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Shoulder Pain

Intervention

Drug:
• EUFLEXXA
2.5 mL of EUFLEXXA (per injection) x 3 injections

Locations

Country	Name	City	State
United States	Georgia Institute for Clinical Research, LLC	Marietta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia Institute for Clinical Research, LLC	Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Reduction in Pain by the Scores.	Greater than 50 percent reduction in pain scores from baseline.	6 months	Yes