Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and efficacy of Zilretta (FX006) in bursal injections and to assess the patient's impression to change in treatments, to their chronic pain.

Official Title
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Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis

Conditions
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Trochanteric Bursitis

Intervention / Treatment
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* Drug: Zilretta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written consent to participate in the study Symptoms consistent with greater trochanteric bursitis for greater than or equal to 3 months prior to screening (patient reported is acceptable) Pain in hip for greater than 15 days over the last month (as reported by the patient). Hip bursitis as determined by clinical examination and clinical features. Where Magnetic Resonance Imaging (MRI) data is available, it will be used to confirm the bursitis diagnosis. Also, pain relief in subjects that have been treated with bursal injections containing an anesthetic (such as ropivacaine) is in itself indicative of bursitis. Body mass index (BMI) less than or equal to 40 kg/m2 Ambulatory and in good general health Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions. Willing to abstain from use of protocol-restricted medications during the study Exclusion Criteria: Hip Arthroplasty Hip osteoarthritis, iliopsoas bursitis, reactive arthritis,rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease History of local infection around the bursa. Lack of pain relief with the intrabursal treatments containing an anesthetic Intra-bursal treatment of any bursa with any of the following agents within three (3) months of screening: any corticosteroid preparation (investigational or marketed, including FX006); and/or six (6) months for any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed). Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of screening. Females who are pregnant or nursing or plan to become pregnant during the study; women who plan to conceive

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zilretta<br> | Drug: Zilretta<br>* Subjects will be injected with the 5ml of FX006. This injection may be followed with up to 3ml of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain from baseline as assessed by the Numeric Pain Rating Scale (NPRS) score | Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable). | Baseline,week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient's impression to change in treatment,to their chronic pain as measured by the Patient Global Impression of Change (PGIC) measure | The PGIC is a 7 point scale ranging from very much improved (1) to very much worsened (7) | Baseline,week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip bursitis, hip pain, Zilretta