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

This study has been completed.
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Arnold J. Weil, M.D., Georgia Institute for Clinical Research, LLC
ClinicalTrials.gov Identifier:
NCT00969501
First received: August 31, 2009
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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 Intervention
Osteoarthritis
Drug: EUFLEXXA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Georgia Institute for Clinical Research, LLC:

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


Enrollment: 32
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EUFLEXXA
ACTIVE CONTROL
Drug: EUFLEXXA
2.5 mL of EUFLEXXA (per injection) x 3 injections

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969501

Locations
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
Principal Investigator: Arnold J. Weil, M.D. Georgia Institute for Clinical Research, LLC
  More Information

No publications provided

Responsible Party: Arnold J. Weil, M.D., M.D./CEO/Principal Investigator, Georgia Institute for Clinical Research, LLC
ClinicalTrials.gov Identifier: NCT00969501     History of Changes
Other Study ID Numbers: EUF-SHO-0001
Study First Received: August 31, 2009
Results First Received: September 5, 2012
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Shoulder Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Arthralgia
Pain
Signs and Symptoms
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014