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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04182672
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 The University of Texas Health Science Center, Houston
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Pritish Bawa, MD
Principal Investigator Affiliation The University of Texas Health Science Center, Houston
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Trochanteric Bursitis
Arms & Interventions

Arms

Experimental: Zilretta

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Houston, Texas

Status

Recruiting

Address

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

Site Contact

Pritish Bawa, MD

[email protected]

713-500-7706

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