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

NCT ID: NCT04065074

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2019-12-30

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.

Conditions

Osteoarthritis, Hip

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

FX006 32 mg

Single intra-articular (IA) injection of FX006 32 mg

Group Type: EXPERIMENTAL

FX006 32 mg

Intervention Type: DRUG

Extended-release 32 mg FX006 IA injection

Interventions

FX006 32 mg

Extended-release 32 mg FX006 IA injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Kelley

Role: STUDY_DIRECTOR

Pacira Pharmaceuticals, Inc

Locations

Noble Clinical Research

Tucson, Arizona, United States

Hope Clinical Research

Canoga Park, California, United States

Biosolutions Clinical Research Center

La Mesa, California, United States

Dream Team Clinical Research

Pomona, California, United States

Lenox Hill Hospital

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FX006-2019-017

Identifier Type: -

Identifier Source: org_study_id