NCT04065074

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	FX006 32 mg	Extended-release 32 mg FX006 IA injection

Timeline

• Start date: 2019-07-30
• Primary completion: 2019-10-11
• Completion: 2019-12-30
• First posted: 2019-08-22
• Last updated: 2024-01-24
• Results posted: 2020-12-01

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study