OsteoarthritisNCT00969501
Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)
A study testing EUFLEXXA in people with Osteoarthritis, run by Georgia Institute for Clinical Research, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- EUFLEXXA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060
About this study
Official title: Investigator Initiated, Exploratory Case Study Three Injections of EUFLEXXA (Sodium Hyaluronate)Treatment of Chronic Shoulder Pain Associated With Osteoarthritis
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.
Read the detailed description
To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- EUFLEXXA
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUFLEXXADrug
2.5 mL of EUFLEXXA (per injection) x 3 injections
| Study group | Role | What they receive |
|---|---|---|
| EUFLEXXA | Experimental | ACTIVE CONTROL Receives: Drug: EUFLEXXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Reduction in Pain by the Scores.
Greater than 50 percent reduction in pain scores from baseline.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Institute for Clinical Research, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Principal investigator, Arnold J. Weil, M.D., Georgia Institute for Clinical Research, LLC
- Investigators
- Arnold J. Weil, M.D., Principal investigator, Georgia Institute for Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969501
- Sponsor's protocol ID
- EUF-SHO-0001
- Status last verified
- Mar 2013
- First submitted
- 31 Aug 2009
- Last updated
- 7 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated, Exploratory Case Study Three Injections of EUFLEXXA (Sodium Hyaluronate)Treatment of Chronic Shoulder Pain Associated With Osteoarthritis
- ClinicalTrials.gov ID
- NCT00969501
- Acronym / sponsor ID
- EUF-SHO-0001
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Georgia Institute for Clinical Research, LLCUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Posted 7 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUFLEXXA | Experimental | Drug: EUFLEXXAACTIVE CONTROL |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUFLEXXA2.5 mL of EUFLEXXA (per injection) x 3 injections | Drug | EUFLEXXA |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnold J. Weil, M.D. principal investigator
Georgia Institute for Clinical Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUFLEXXA in people with Osteoarthritis, run by Georgia Institute for Clinical Research, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Reduction in Pain by the Scores. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.