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Completed

NCT Number: NCT04182672

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

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.

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Key information

Conditions

Trochanteric Bursitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FX006

Drug

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.

Primary outcomes

  1. Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score

    Time frame: Baseline,week 12

    Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable).

Secondary outcomes

  1. Patient Global Impression of Change (PGIC) Score

    Time frame: 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)

    • No change (or condition has got worse)
    • Almost the same, hardly any change at all
    • A little better, but no noticeable change
    • Somewhat better, but the change has not made any real difference
    • Moderately better, and a slight but noticeable change
    • Better, and a definite improvement that has made a real and worthwhile difference
    • A great deal better, and a considerable improvement that has made all the difference

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2019
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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