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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Recruiting

CT.gov ID

NCT04182672

Collaborator

Flexion Therapeutics, Inc. (Industry)

Enrollment

Location

Arm

24.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Trochanteric Bursitis	Drug: Zilretta	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 12, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zilretta	Drug: Zilretta 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.

Arm

Intervention/Treatment

Experimental: Zilretta

Drug: Zilretta

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.

Outcome Measures

Primary Outcome Measures

Change in pain from baseline as assessed by the Numeric Pain Rating Scale (NPRS) score [Baseline,week 12]
Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable).

Secondary Outcome Measures

Change in patient's impression to change in treatment,to their chronic pain as measured by the Patient Global Impression of Change (PGIC) measure [Baseline,week 12]
The PGIC is a 7 point scale ranging from very much improved (1) to very much worsened (7)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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