NCT03793010

Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.

Detailed description

This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline. FX006 or saline placebo will be administered as a single IA injection with a 12-week follow-up period in the double-blind phase. Patients participating in Part I of the study will be treated with a single IA injection of either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20, and 24. The patients will be discontinued at the time of notification by the Investigator. Patients participating in Part II of the study will be treated with a single IA injection of either 32 mg FX006 or normal saline and will return for follow up visits at Weeks 12, 16, 20, and 24. Patients participating in Part II of the study that are not clinically indicated for a second injection at Week 12 will return to the clinic at Weeks 16, 20, and 24 and will receive an open-label injection of FX006 at the first evaluation where the patient has been determined to meet all criteria. Patients will then return for follow-up visits every 4 weeks for 12 weeks post second injection and will complete the study 12 weeks post second injection (e.g., Week 24, 28, 32, or 36 depending on when the patient receives the open-label injection). Patients participating in Part II of the study who are not eligible for a second injection after evaluation at Weeks 12, 16, 20, and 24 will complete the study at the Week 24 visit and complete the End of Study (EOS) assessments.

Conditions

• Osteoarthritis, Hip

Interventions

Type	Name	Description
DRUG	FX006	Single Intra-articular injection
DRUG	Normal saline	Single Intra-articular injection

Timeline

• Start date: 2018-12-12
• Primary completion: 2019-08-07
• Completion: 2019-08-07
• First posted: 2019-01-04
• Last updated: 2024-01-24
• Results posted: 2020-09-14

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study