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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00969501
Recruitment Status : Completed
First Posted : September 1, 2009
Results First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Arnold J. Weil, M.D., Georgia Institute for Clinical Research, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: EUFLEXXA Not Applicable

Detailed Description:
To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigator Initiated, Exploratory Case Study Three Injections of EUFLEXXA (Sodium Hyaluronate)Treatment of Chronic Shoulder Pain Associated With Osteoarthritis
Study Start Date : August 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: EUFLEXXA
ACTIVE CONTROL
 Drug: EUFLEXXA
2.5 mL of EUFLEXXA (per injection) x 3 injections


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With a Reduction in Pain by the Scores. [ Time Frame: 6 months ]
    Greater than 50 percent reduction in pain scores from baseline.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969501


Locations
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United States, Georgia
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States, 30060
Sponsors and Collaborators
Georgia Institute for Clinical Research, LLC
Ferring Pharmaceuticals
Investigators
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Principal Investigator: Arnold J. Weil, M.D. Georgia Institute for Clinical Research, LLC
More Information
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Responsible Party: Arnold J. Weil, M.D., M.D./CEO/Principal Investigator, Georgia Institute for Clinical Research, LLC
ClinicalTrials.gov Identifier: NCT00969501    
Other Study ID Numbers: EUF-SHO-0001
First Posted: September 1, 2009    Key Record Dates
Results First Posted: May 7, 2013
Last Update Posted: May 7, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Osteoarthritis
Shoulder Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Arthralgia
Pain
Neurologic Manifestations