Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthri… (NCT04065074) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthritis of the Hip
United States16 participantsStarted 2019-07-30
Plain-language 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.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 co…
What they're measuring
1
Number of Patients With Successful Study Drug Administrations