Osteoarthritis, Hip
Conditions
Keywords
Osteoarthritis, Hip, Intra-articular, Injection
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.
Interventions
DRUGFX006 32 mg
Extended-release 32 mg FX006 IA injection
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Successful Study Drug Administrations | Day 1 | Successful study drug administration, defined as Injector reporting complete study drug administration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FX006 32 mg Single intra-articular (IA) injection of FX006 32 mg
FX006 32 mg: Extended-release 32 mg FX006 IA injection | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Protocol Non-Compliance after injection | 1 |
Baseline characteristics
| Characteristic | FX006 32 mg |
|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 7.82 |
| Body Mass Index (BMI) | 31.56 kg/m^2 STANDARD_DEVIATION 6.785 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
Primary
Number of Patients With Successful Study Drug Administrations
Successful study drug administration, defined as Injector reporting complete study drug administration.
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FX006 32 mg | Number of Patients With Successful Study Drug Administrations | 12 Participants |
90% CI: [0.51, 0.9]