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

Osteoarthritis, Hip Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065074
• Other study ID #: FX006-2019-017
• Status: Completed
• Phase: Phase 2
• Start date: July 30, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2024
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 30, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Drug:
• FX006 32 mg
Extended-release 32 mg FX006 IA injection

Locations

Country	Name	City	State
United States	Hope Clinical Research	Canoga Park	California
United States	Biosolutions Clinical Research Center	La Mesa	California
United States	Lenox Hill Hospital	New York	New York
United States	Dream Team Clinical Research	Pomona	California
United States	Noble Clinical Research	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Successful Study Drug Administrations	Successful study drug administration, defined as Injector reporting complete study drug administration.	Day 1