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Corticosteroid
ZILRETTA for Shoulder Osteoarthritis
Phase 3
Recruiting
Research Sponsored by Pacira Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Shoulder pain due to OA for >15 days over the last month as reported by the subject
Grade 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto classification system as confirmed by X-ray taken at, or within 6 months of, the Screening Visit and read by the central reader
Must not have
Subjects with symptomatic rotator cuff pathology or evidence of cuff tear arthropathy
Subjects with symptomatic arthritis in other joints of the index shoulder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial is testing the effectiveness of ZILRETTA in reducing pain in people with glenohumeral osteoarthritis when compared to a placebo. The secondary objectives include comparing the pain
Who is the study for?
This trial is for individuals with shoulder osteoarthritis, specifically in the glenohumeral joint. Participants should have a history of pain due to their condition and be suitable candidates for intra-articular injection treatments.
What is being tested?
The study aims to compare the effectiveness and safety of ZILRETTA (an extended-release corticosteroid) against a placebo (normal saline) and an immediate-release steroid (TCA-IR), all administered through single-dose injections directly into the shoulder joint.
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of infection, changes in blood sugar levels, temporary increase in pain, allergic reactions, or other steroid-related effects such as mood swings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had shoulder pain for more than 15 days in the last month.
Select...
My shoulder joint shows moderate to severe arthritis on an X-ray.
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My shoulder pain scores between 4 and 9 on average over the last week.
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My shoulder pain score is between 5 and 9.
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I am between 50 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have shoulder pain or damage due to a rotator cuff issue.
Select...
I have painful arthritis in the shoulder being studied.
Select...
My shoulder condition is not due to major dysplasia or specific diseases like acromegaly.
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I have or had an infection in my shoulder or at the site where I might get an injection.
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I am using muscle relaxants and applying treatments directly to my shoulder.
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I have no history of serious fungal, tuberculosis infections, or eye herpes.
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I have had radiation treatment on my shoulder area.
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I have a history of sarcoidosis, amyloidosis, or active Cushing's syndrome.
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I have no planned surgeries on my arms, neck, or any that need restricted meds during the study.
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I haven't had any cancer except for skin cancer in the last 5 years.
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I have a disorder that affects my lymph cells.
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My shoulder has a fracture or bone damage due to poor blood supply.
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I have a history of specific arthritis types or autoimmune diseases.
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I am currently taking corticosteroids as prescribed.
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I am taking SSRIs or SNRIs with a dose that hasn't been stable.
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I had surgery on my shoulder within the last 5 years.
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I am allergic to triamcinolone or PLGA.
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I have ongoing pain in both of my shoulders.
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I have surgical hardware in my shoulder from a previous operation.
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I haven't taken IV antibiotics in the last 4 weeks or oral antibiotics in the last 2 weeks.
Select...
I am not part of the study's research team.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ZILRETTAExperimental Treatment1 Intervention
100 subjects will receive 32 mg ZILRETTA
Group II: TCA-IRActive Control1 Intervention
100 subjects will receive 40 mg TCA-IR
Group III: PlaceboPlacebo Group1 Intervention
50 subjects will receive normal saline placebo
Find a Location
Who is running the clinical trial?
Pacira Pharmaceuticals, IncLead Sponsor
138 Previous Clinical Trials
13,791 Total Patients Enrolled
1 Trials studying Shoulder Arthritis
100 Patients Enrolled for Shoulder Arthritis
Nino Joy, MDStudy DirectorPacira Pharmaceuticals, Inc
1 Previous Clinical Trials
24 Total Patients Enrolled