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

• Sponsor: Georgia Institute for Clinical Research, LLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT00969501
• Collaborator: Ferring Pharmaceuticals (Industry)
• Enrollment: 32
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• 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: Aug 1, 2009
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EUFLEXXA ACTIVE CONTROL	Drug: EUFLEXXA; 2.5 mL of EUFLEXXA (per injection) x 3 injections

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Reduction in Pain by the Scores. [6 months]

   Greater than 50 percent reduction in pain scores from baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Sep 1, 2009
• Last Update Posted: May 7, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Osteoarthritis; Shoulder Pain

Study Results

Participant Flow

Arm/Group Title	EUFLEXXA
Arm/Group Description	All subjects received three injections (one each, in weeks 0 [baseline], 1, and 2 of high molecular weight hyaluronate (2.5 mL each) using standard injection techniques in the anterior or posterior approach. Sub- jects were evaluated at screening and baseline, and at weeks 1, 2, 6, 14, 26, and 27 (last evaluation by telephone).
Period Title: Overall Study
STARTED	32
COMPLETED	27
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	EUFLEXXA
Arm/Group Description	ACTIVE CONTROL
Overall Participants	32
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	31 96.9%
>=65 years	1 3.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.1 (1)
Sex: Female, Male (Count of Participants)
Female	16 50%
Male	16 50%
Region of Enrollment (participants) [Number]
United States	32 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Reduction in Pain by the Scores.
Description	Greater than 50 percent reduction in pain scores from baseline.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description



Arm/Group Title	EUFLEXXA
Arm/Group Description	ACTIVE CONTROL
Measure Participants	27
Number [participants]	25 78.1%

Adverse Events

Arm/Group Title	EUFLEXXA
Arm/Group Description	ACTIVE CONTROL
All Cause Mortality
	EUFLEXXA
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	EUFLEXXA
	Affected / at Risk (%)	# Events
Total	0/32 (0%)
Other (Not Including Serious) Adverse Events
	EUFLEXXA
	Affected / at Risk (%)	# Events
Total	0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.