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

Primary Purpose

Trochanteric Bursitis

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zilretta
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trochanteric Bursitis focused on measuring Hip bursitis, hip pain, Zilretta

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zilretta

Arm Description

Outcomes

Primary Outcome Measures

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).

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
The PGIC is a 7 point scale ranging from very much improved (1) to very much worsened (7)

Full Information

First Posted
November 27, 2019
Last Updated
October 4, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Flexion Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04182672
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
December 14, 2022 (Anticipated)
Study Completion Date
December 14, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Flexion Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trochanteric Bursitis
Keywords
Hip bursitis, hip pain, Zilretta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zilretta
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zilretta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain from baseline as assessed by the Numeric Pain Rating Scale (NPRS) score
Description
Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable).
Time Frame
Baseline,week 12
Secondary Outcome Measure Information:
Title
Change in patient's impression to change in treatment,to their chronic pain as measured by the Patient Global Impression of Change (PGIC) measure
Description
The PGIC is a 7 point scale ranging from very much improved (1) to very much worsened (7)
Time Frame
Baseline,week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pritish Bawa, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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