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

Trochanteric Bursitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182672
• Other study ID #: HSC-MS-18-0672
• Status: Completed
• Phase: Phase 2
• Start date: August 12, 2020
• Est. completion date: December 14, 2022

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Trochanteric Bursitis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Pacira Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline,week 12
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); 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	from start of treatment to week 12 of treatment