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

NCT00969501 | Completed Results DMC

• 1 other identifier: EUF-SHO-0001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Reduction in Pain by the Scores.

  Greater than 50 percent reduction in pain scores from baseline.

  6 months

Study Arms (1)

EUFLEXXA

EXPERIMENTAL

ACTIVE CONTROL

Drug: EUFLEXXA

Interventions

EUFLEXXA DRUG

2.5 mL of EUFLEXXA (per injection) x 3 injections

EUFLEXXA

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be age 30 to 79
• Give written informed consent for trial participation
• Must have shoulder pain for a minimum of 6 months but less than 5 years
• Must have a Pain Intensity Score of \> 5
• Must be willing to discontinue all pain medications 24 hours prior to each clinic visit
• Must have a stable pain medication regime 1 month prior to treatment
• Agrees to maintain pain medication doses within 30% (increase or decrease) of the Baseline dose

You may not qualify if:

• Any history of full thickness rotator cuff tear or joint effusion
• A diagnosis of chronic acromioclavical disease, active epicondylitis, or active Carpal Tunnel Disease
• Has had more than 2 corticosteroid injections in the previous 3 months
• Has an infection or an inflammatory condition of the trial shoulder
• 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
• Has severe joint effusion of the trial shoulder
• Has a diagnosis of cancer within the past 5 years (basal cell carcinoma is not excluded)
• Has had any hyaluronate agent or other chondroprotective agents in the trial shoulder
• Has a hypersensitivity to HA products, eggs, birds or feathers
• Has a history of substance abuse, alcohol abuse or psychiatric condition, that in the opinion of the Investigator, will potentially interfere with participation
• 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
• Is actively involved in a litigation involving Workers' Compensation
• Is a female that is pregnant, planning to become pregnant or is lactating
• Has participated in a clinical trial within the past four weeks

Sponsors & Collaborators

• Georgia Institute for Clinical Research, LLC: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Georgia Institute for Clinical Research, LLC

Marietta, Georgia, 30060, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Arnold Weil, MD
• Organization: Georgia Institute for Clinical Research, LLC

research@lowbackpain.com

770-421-2030

Study Officials

• Arnold J. Weil, M.D.

  Georgia Institute for Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D./CEO/Principal Investigator

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: May 7, 2013
• Results First Posted: May 7, 2013

Record last verified: 2013-03

Locations

US (1)