Trochanteric Bursitis
Conditions
Keywords
Hip bursitis, hip pain
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.
Interventions
DRUGFX006
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.
Sponsors
Pacira Pharmaceuticals, Inc
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FX006 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | FX006 |
|---|---|
| Age, Continuous | 62.5 years |
| Baseline Numeric Pain Rating Scale (NPRS) Score | 5 score on a scale |
| Baseline Patient Global Impression of Change (PGIC) score | 2 score on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 6 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
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).
Time frame: Baseline,week 12
Population: Data were not collected for two participants in the FX006 arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FX006 | Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score | -2.25 score on a scale | Standard Deviation 3.64 |
Secondary
Patient Global Impression of Change (PGIC) Score
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
Time frame: from start of treatment to week 12 of treatment
Population: Data were not collected for two participants in the FX006 arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FX006 | Patient Global Impression of Change (PGIC) Score | 5 score on a scale |