Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis
Condition: Trochanteric Bursitis
MeSH terms: Bursitis
Intervention: FX006
Intervention description: 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.
Intervention MeSH terms: FX006
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hip bursitis; hip pain

Summary:

      The purpose of this study is to determine the safety and efficacy of FX006 in bursal
      injections and to assess the patient's impression to change in their chronic pain, following
      treatment.
    

Eligibility criteria:

        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