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

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
FX006	FX006	-

Primary Outcome Measures

Name	Time	Method
Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score	Baseline,week 12	Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable).

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC) Score	from start of treatment to week 12 of treatment	The PGIC is a 7 point scale ranging from very much improved (1) to very much worsened (7) 1. No change (or condition has got worse) 2. Almost the same, hardly any change at all 3. A little better, but no noticeable change 4. Somewhat better, but the change has not made any real difference 5. Moderately better, and a slight but noticeable change 6. Better, and a definite improvement that has made a real and worthwhile difference 7. A great deal better, and a considerable improvement that has made all the difference