Infinite Clinical Research Inc | Miami, FL
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Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placebo
Secondary Objective:
Full description
This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of ZILRETTA in subjects with glenohumeral OA. This study will be conducted at approximately 25 study sites in the United States. Subjects will be screened to confirm the diagnosis of OA and eligibility based on the Inclusion and Exclusion Criteria. Approximately 250 male or female subjects, 50 to 80 years of age inclusive, will be enrolled, randomized to 1 of 3 treatment groups (2:2:1), and treated with a single IA injection of either:
The study will involve a Screening period (a minimum of 10 days, up to a maximum of 35 days), pre-treatment phase, dosing at Baseline/Day 1, and 8 additional outpatient visits at Weeks 2, 4, 8, 12, 16, 18, 20, and 24/End of Study (EOS) during the study.
At specified times throughout the study, subjects will undergo physical examinations, index shoulder assessments, and index shoulder X-rays; blood will be collected for laboratory safety tests; and vital signs will be collected.
Information regarding adverse events (AEs) and prior and concomitant medications and treatments will be collected from the time of signing the Informed Consent Form (ICF) through the Week 24/EOS visit. Information regarding rescue medication usage, Average and Worst daily Pain score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) in the index shoulder, and Sleep Interference (SI) will be completed daily via an electronic diary (eDiary) and reviewed for compliance by site staff at each study visit.
At the Screening Visit, subjects will be registered in the eDiary and receive instructions on its use. Subjects will complete accurate pain reporting (APR) and placebo response reduction (PRR) training prior to completing all questionnaires.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Disease-related criteria
Subjects who cannot washout of prohibited medications (eg, opioids, other analgesics, and tetrahydrocannabinol (THC) and cannabidiol (CBD) containing products) or restricted medications.
Has symptomatic arthritis in other joints of the index shoulder (eg, acromioclavicular joint, sternoclavicular joint, or scapulothoracic joint), which is the primary source of pain in the opinion of the Investigator.
Has symptomatic rotator cuff pathology by physical examination or evidence of cuff tear arthropathy by radiograph.
Has clinical symptomatic chronic bilateral shoulder pain (any condition causing pain in the non- index shoulder).
Has a subchondral bone insufficiency fracture or humeral head necrosis/collapse (including bone infarct) in the index shoulder based on X-ray used for study qualification.
Has a prior ipsilateral proximal humerus fracture or scapula fracture to the index shoulder within 2 years of Screening Visit.
Has been diagnosed with adhesive capsulitis ("frozen shoulder") in the index shoulder, within 1 year of the Screening Visit.
Has a previous shoulder injury (eg, dislocation or clavicle fracture) in the index shoulder which resulted in functional limitation ≥1 month prior to the Screening Visit.
Prior surgery on the index shoulder (less than 5 years), either open or arthroscopic. Should not have any retained hardware.
Has an index shoulder with major dysplasia or congenital abnormality, osteochondritis dissecans, acromegaly, ochronosis, hemochromatosis, Wilson's disease, primary osteochondromatosis, chondrolysis from a pain pump, or a history of avascular necrosis with secondary OA.
Has current or history of infection (eg, osteomyelitis) in the index shoulder or current skin infection at injection site.
Has any concurrent chronic pain condition within 1 month prior to the Screening Visit (subject self- report acceptable), including but not limited to, cervical spine pain or conditions causing radicular pain or peripheral nerve injury/entrapment (eg, brachial plexus injury or suprascapular nerve entrapment); diabetic neuropathy; post-herpetic neuralgia; post-stroke pain; or fibromyalgia that may affect sensation of the index shoulder.
painDETECT Questionnaire (PD-Q) score >18 during Screening Visit.
History or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease, systemic lupus erythematosus, or calcium pyrophosphate dihydrate crystal deposition (CPPD), gout, or other autoimmune diseases.
Any planned surgeries in the upper limbs and/or cervical spine during the study period, or any other surgery during the study period that would require use of a restricted medication.
Previous or concomitant treatment-related criteria
Presence of surgical hardware or other foreign body due to open or arthroscopic cartilage transplant or bone grafting procedures in the index shoulder.
Use of muscle relaxants (eg, cyclobenzaprine, tetrazepam, and diazepam) and topical therapies (eg, NSAIDs, CBD oil, capsaicin, lidocaine patches, or other local treatments) applied to the index shoulder.
The use corticosteroids as follows:
IA treatment of index shoulder with any of the following agents within 6 months of Screening: hyaluronic acid (investigational or marketed) or any biologic agent (eg, platelet rich plasma [PRP] injection, stem cells, prolotherapy, and amniotic fluid-derived product).
Significant changes with regard to physical activity, physical therapy, or lifestyle within 1 month of the Screening Visit, or any planned changes throughout the duration of the study.
Use of selective serotonin/norepinephrine reuptake inhibitors (SSRIs/SNRIs) (eg, fluoxetine, fluvoxamine, citalopram, escitalopram, sertraline, duloxetine, and venlafaxine, milnacipran) if the dose is not stable for at least 3 months prior to Screening Visit and must remain stable throughout the study.
Any treatment with acupuncture and/or transcutaneous electrical nerve stimulation (TENS) within 3 months of Screening Visit.
Subject-related criteria
Females who are pregnant or nursing or plan to become pregnant within 12 months after dosing; men whose partner plans to conceive within 12 months after dosing.
Subjects with clinically relevant level of pain catastrophizing defined as Pain Catastrophizing Scale (PCS) score of ≥30 at Screening Visit.
Known or suspected hypersensitivity to any form of triamcinolone or poly (lactic-co-glycolic) acid (PLGA).
Laboratory evidence of infection with human immunodeficiency virus (HIV), positive test for hepatitis B surface antigen (HBsAg), or positive serology for hepatitis C virus (HCV) with positive test for HCV ribonucleic acid (RNA) on recent testing.
A medical history suggesting the subject will or is likely to require a course of systemic corticosteroids during the study.
History or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis) or of ocular herpes simplex.
History of sarcoidosis, amyloidosis or active Cushing's syndrome.
Use of immunomodulators, immunosuppressives, or chemotherapeutic agents within 5 years of Screening.
Active or history of malignancy within 5 years of Screening, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or effectively managed cervical carcinoma.
History of radiation treatment involving the index shoulder girdle.
Active substance abuse (drugs or alcohol) or history of substance abuse within the past 12 months of Screening.
Has received a live vaccine within 3 months of Baseline/Day 1.
Has received vaccination within 1 week prior to the Screening Visit and local injection pain has not resolved.
Use of any other investigational drug, biologic, or device within 3 months of Screening Visit.
Any bacterial or viral infection requiring IV antibiotics within 4 weeks of Baseline/Day 1 or oral antibiotics within 2 weeks of Baseline/Day 1.
Any other clinically significant acute or chronic medical conditions (eg, poorly controlled diabetes with hemoglobin A1c [HbA1c] of greater than 9.5%) that, in the judgment of the Investigator, could compromise subject safety, preclude the use of an IA corticosteroid, limit the subject's ability to complete the study, or compromise the objectives of the study.
Subjects contraindicated to the use of acetaminophen/paracetamol (allowed rescue pain medicine) per National Product Labeling and Investigator's judgment.
Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof directly involved in the conduct of the study.
Primary purpose
Allocation
Interventional model
Masking
250 participants in 3 patient groups, including a placebo group
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Central trial contact
Jennifer Gordon
Data sourced from clinicaltrials.gov
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