Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanter… (NCT04182672) | Clinical Trial Compass
CompletedPhase 2
Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis
United States22 participantsStarted 2020-08-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 si…
What they're measuring
1
Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score
Timeframe: Baseline,week 12
Trial details
NCT IDNCT04182672
SponsorThe University of Texas Health Science Center, Houston