Clinical trial NCT04065074: Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthritis of the Hip
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Hip
Keywords: Osteoarthritis
Hip
Intra-articular
Injection
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2019-08-22
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Number of Patients With Successful Study Drug Administrations
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: La Mesa
country: United States
facility: Biosolutions Clinical Research Center
state: California
city: Pomona
country: United States
facility: Dream Team Clinical Research
state: California
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
affiliation: Pacira Pharmaceuticals, Inc
name: Scott Kelley
role: STUDY_DIRECTOR
References: