Osteoarthritis, HipPhase 2NCT04065074

Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthritis of the Hip

A Phase 2 study testing FX006 32 mg in people with Osteoarthritis, Hip, run by Pacira Pharmaceuticals, Inc at 5 sites 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

This is a multi-center, single-arm, open-label study of FX006 in patients with hip OA. A maximum number of approximately 30 patients may be enrolled in this protocol. All enrolled patients will receive a single intra-articular (IA) injection of FX006. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Osteoarthritis, Hip
What is being tested?: FX006 32 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 5 sitesUnited States
Study dates: 30 Jul 2019to 30 Dec 2019
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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Patients 40 to 80 years of age, inclusive, on the day of consent
Body Mass Index (BMI) ≤ 40 kg/m^2
Has a documented clinical diagnosis of unilateral or bilateral hip OA for at least six months
Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by local read of X-ray obtained during Screening or ≤ 6 months of Screening visit
Has clinically significant pain in the index hip

Who cannot join

Has a history of hypersensitivity to triamcinolone acetonide, PLGA or lidocaine
Is receiving anticoagulants (including warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin, ritonavir or cobicistat)
Has had any previous surgery on the index hip
Presence of surgical hardware or other foreign body in the index hip
Has a history of infection of the index hip
Has a diagnosis of other disorders in the index hip that can cause pain

Show all 15Show fewer

Has received any intra-articular injection in the index hip of corticosteroids, investigational (including FX006) or marketed (including Zilretta®) within the 3 months prior to Screening
Has had trauma to the index hip in the past 3 months requiring immobilization
Has a history or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis), or of ocular herpes simplex
Has within the past 3 months received corticosteroids by mouth, or by parenteral injection. Multiple courses or chronic intermittent use of inhaled, intranasal, or topical steroids is also exclusionary. Single courses of 14 days or less by those routes are permitted
Has, at screening, or any time prior to day of scheduled injection (Day 1), clinical suspicion of local or systemic infection, including any infection in the index leg.
Has a history of or active significant concomitant illness (known or suspected)
Any bacterial or viral infection requiring parental antibiotics within 4 weeks of Day 1 or oral antibiotics within 2 weeks of Day 1
Is a woman who is pregnant, nursing, lactating, or plans to become pregnant during the study
Is a man who plans to conceive during the study

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Hope Clinical Research
Canoga Park, California, 91303
Biosolutions Clinical Research Center
La Mesa, California, 91942
Lenox Hill Hospital
New York, New York, 10075
Dream Team Clinical Research
Pomona, California, 91767
Noble Clinical Research
Tucson, Arizona, 85704

Other trials in United States

About this study

Official title: A Single-arm, Open-label Study to Evaluate a Procedure for Intra-articular (IA) Injection of FX006 in Patients With Osteoarthritis (OA) of the Hip

Read the detailed description

This is a multi-center, single-arm, open-label study in patients with hip OA to evaluate a procedure for intra-articular injection of FX006 in patients with hip OA. A maximum number of approximately 30 patients may be enrolled in this protocol.

All enrolled patients will receive a single intra-articular (IA) injection on Day 1 and be followed for 8 weeks.

Conditions: Osteoarthritis, Hip
Being tested: FX006 32 mg
Keywords: Osteoarthritis, Hip, Intra-articular, Injection
Medical subject headings: Osteoarthritis, Hip, Osteoarthritis

What participants receive

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

FX006 32 mgDrug
Extended-release 32 mg FX006 IA injection

Study groups in NCT04065074
Study group	Role	What they receive
FX006 32 mg	Experimental	Single intra-articular (IA) injection of FX006 32 mg Receives: Drug: FX006 32 mg

What is being measured

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

Number of Patients With Successful Study Drug Administrations
Successful study drug administration, defined as Injector reporting complete study drug administration.
Measured: Day 1

Timeline

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

30 Jul 201930 Dec 2019

First posted22 Aug 2019
Study start30 Jul 2019
Primary completion11 Oct 2019
Study completion30 Dec 2019

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 Osteoarthritis, HipStudies of the same condition, open and under way.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04065074
Sponsor's protocol ID: FX006-2019-017
Status last verified: Jan 2024
First submitted: 12 Aug 2019
Last updated: 24 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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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Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
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Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
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Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck

All Osteoarthritis, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Open-label Study to Evaluate a Procedure for Intra-articular (IA) Injection of FX006 in Patients With Osteoarthritis (OA) of the Hip
ClinicalTrials.gov ID: NCT04065074
Acronym / sponsor ID: FX006-2019-017
Conditions: Osteoarthritis, Hip
Keywords: Osteoarthritis, Hip, Intra-articular, Injection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: 30 Jul 2019 (actual)
Primary completion: 11 Oct 2019 (actual)
Study completion: 30 Dec 2019 (actual)
First posted: 22 Aug 2019 (actual)
Results: Posted 1 Dec 2020

Clinical summary

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

Detailed description

All enrolled patients will receive a single intra-articular (IA) injection on Day 1 and be followed for 8 weeks.

Study design

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

Arm	Type	Receives
FX006 32 mg	Experimental	Drug: FX006 32 mgSingle intra-articular (IA) injection of FX006 32 mg

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Patients 40 to 80 years of age, inclusive, on the day of consent
Body Mass Index (BMI) ≤ 40 kg/m^2
Has a documented clinical diagnosis of unilateral or bilateral hip OA for at least six months
Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by local read of X-ray obtained during Screening or ≤ 6 months of Screening visit

Key exclusion criteria (15 listed)

Has a history of hypersensitivity to triamcinolone acetonide, PLGA or lidocaine
Is receiving anticoagulants (including warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin, ritonavir or cobicistat)
Has had any previous surgery on the index hip
Presence of surgical hardware or other foreign body in the index hip
Has a history of infection of the index hip

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
FX006 32 mgExtended-release 32 mg FX006 IA injection	Drug	FX006 32 mg

Primary outcome

Number of Patients With Successful Study Drug Administrations
Time frame: Day 1
Successful study drug administration, defined as Injector reporting complete study drug administration.

Results and safety

Results posted to the registry on 1 Dec 2020, 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 32 mg	16	14

Primary outcome: Number of Patients With Successful Study Drug Administrations

Time frame: Day 1. Count of participants. Unit: Participants

Measure	FX006 32 mg n = 16
Value	12

FX006 32 mg: Proportion of Successful Administrations: 0.75 (90% CI 0.51 to 0.90)

Adverse events

Time frame: Adverse event data was collected from signing of informed consent to Last Visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FX006 32 mg	1 of 16 (6.3%)	0 of 16 (0%)	0 of 16

Limitations and caveats (from the sponsor): Only 16 of the planned 30 patients were enrolled in this trial as the procedure for intra-articular injection of FX006 in patients with hip OA did not reduce the incidence of incomplete study drug administrations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis, Hip

Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
Hip OA
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck

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.

Scott Kelley study director

Pacira Pharmaceuticals, Inc

5 sites 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 32 mg in people with Osteoarthritis, Hip, run by Pacira Pharmaceuticals, Inc at 5 sites 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 6 inclusion and 15 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 24 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 5 sites 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 1 Dec 2020). 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?

Number of Patients With Successful Study Drug Administrations (time frame: Day 1). 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 NCT04065074.

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 24 Jan 2024.