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

NCT04182672 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HSC-MS-18-0672
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Trochanteric Bursitis

Keywords

Hip bursitis; hip pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Global Impression of Change (PGIC) Score

  from start of treatment to week 12 of treatment

Study Arms (1)

FX006

EXPERIMENTAL

Drug: FX006

Interventions

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.

FX006

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

FX006

Limitations and Caveats

Adverse event relating to fall was not related to the treatment.

Results Point of Contact

• Title: Pritish Bawa, MD
• Organization: The University of Texas Health Science Center at Houston

Pritish.Bawa@uth.tmc.edu

713-500-7702

Study Officials

• Pritish Bawa, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: August 12, 2020
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: January 2, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)