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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2022
  • participants needed
    24
  • sponsor
    The University of Texas Health Science Center, Houston
Updated on 1 November 2021

Summary

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.

Details
Condition trochanteric bursitis
Treatment Zilretta
Clinical Study IdentifierNCT04182672
SponsorThe University of Texas Health Science Center, Houston
Last Modified on1 November 2021

Eligibility

Yes No Not Sure

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
Females who are pregnant or nursing or plan to become pregnant during the study; women who plan to conceive
Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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