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

NCT ID: NCT00969501

Last Updated: 2013-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-08-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EUFLEXXA

ACTIVE CONTROL

Group Type: EXPERIMENTAL

EUFLEXXA

Intervention Type: DRUG

2.5 mL of EUFLEXXA (per injection) x 3 injections

Interventions

EUFLEXXA

2.5 mL of EUFLEXXA (per injection) x 3 injections

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Georgia Institute for Clinical Research, LLC

OTHER

Sponsor Role: lead

Responsible Party

Arnold J. Weil, M.D.

M.D./CEO/Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arnold J. Weil, M.D.

Role: PRINCIPAL_INVESTIGATOR

Georgia Institute for Clinical Research, LLC

Locations

Georgia Institute for Clinical Research, LLC

Marietta, Georgia, United States

Countries

United States

Other Identifiers

EUF-SHO-0001

Identifier Type: -

Identifier Source: org_study_id