Clinical trial NCT04182672: Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis
Official title: Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trochanteric Bursitis
Keywords: Hip bursitis
hip pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2019-12-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score
timeFrame: Baseline,week 12
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC) Score
timeFrame: from start of treatment to week 12 of treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Pritish Bawa, MD
role: PRINCIPAL_INVESTIGATOR
References: