Trochanteric BursitisPhase 2NCT04182672

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

A Phase 2 study testing FX006 in people with Trochanteric Bursitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Trochanteric Bursitis
What is being tested?: FX006
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 12 Aug 2020to 14 Dec 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

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
Being tested: FX006
Keywords: Hip bursitis, hip pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FX006Drug
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.

Study groups in NCT04182672
Study group	Role	What they receive
FX006	Experimental	Not described Receives: Drug: FX006

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline,week 12

Secondary outcomes (1)

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)
1. No change (or condition has got worse)
2. Almost the same, hardly any change at all
3. A little better, but no noticeable change
4. Somewhat better, but the change has not made any real difference
5. Moderately better, and a slight but noticeable change
6. Better, and a definite improvement that has made a real and worthwhile difference
7. A great deal better, and a considerable improvement that has made all the difference
Measured: from start of treatment to week 12 of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 202014 Dec 2022

First posted2 Dec 2019
Study start12 Aug 2020
Primary completion14 Dec 2022
Study completion14 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Trochanteric BursitisStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04182672
Sponsor's protocol ID: HSC-MS-18-0672
Status last verified: Dec 2023
First submitted: 27 Nov 2019
Last updated: 2 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enhancing Exercise Adherence Among Patients With Lateral Hip Pain
Greater Trochanter Pain Syndrome, Hip Pain
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ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain
Greater Trochanteric Pain Syndrome, Greater Trochanteric Pain Syndrome of Both Lower Limbs
Not yet recruiting
Comparing Standard Care Approaches for Greater Trochanteric Pain Syndrome in General Practice
Greater Trochanteric Pain Syndrome, Gluteal Tendinopathy
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Recruiting
HILT in Greater Trochanteric Pain Syndrome
Greater Trochanteric Pain Syndrome

All Trochanteric Bursitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis
ClinicalTrials.gov ID: NCT04182672
Acronym / sponsor ID: HSC-MS-18-0672
Conditions: Trochanteric Bursitis
Keywords: Hip bursitis, hip pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: Pacira Pharmaceuticals, Inc
Study start: 12 Aug 2020 (actual)
Primary completion: 14 Dec 2022 (actual)
Study completion: 14 Dec 2022 (actual)
First posted: 2 Dec 2019 (actual)
Results: Posted 2 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FX006	Experimental	Drug: FX006

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (8 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FX006Subjects 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.	Drug	FX006

Primary outcome

Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score
Time frame: Baseline,week 12
Numeric Pain Rating Scale total score ranges from 0 (no pain) to 10 (most intense pain imaginable).

1 secondary outcome

Patient Global Impression of Change (PGIC) Score
Time frame: from start of treatment to week 12 of treatment

Results and safety

Results posted to the registry on 2 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FX006	22	22

Primary outcome: Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score

Time frame: Baseline,week 12. Mean (Standard Deviation). Unit: score on a scale

Measure	FX006 n = 20
Value	-2.25 (3.64)

Population analysed: Data were not collected for two participants in the FX006 arm.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FX006	0 of 22 (0%)	6 of 22 (27.3%)	0 of 22

Limitations and caveats (from the sponsor): Adverse event relating to fall was not related to the treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Trochanteric Bursitis

Recruiting
Enhancing Exercise Adherence Among Patients With Lateral Hip Pain
Greater Trochanter Pain Syndrome, Hip Pain
Recruiting
ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain
Greater Trochanteric Pain Syndrome, Greater Trochanteric Pain Syndrome of Both Lower Limbs
Not yet recruiting
Comparing Standard Care Approaches for Greater Trochanteric Pain Syndrome in General Practice
Greater Trochanteric Pain Syndrome, Gluteal Tendinopathy
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Recruiting
HILT in Greater Trochanteric Pain Syndrome
Greater Trochanteric Pain Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pritish Bawa, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FX006 in people with Trochanteric Bursitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain From Baseline as Assessed by the Numeric Pain Rating Scale (NPRS) Score (time frame: Baseline,week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04182672.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.