NCT03378076

Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.

Detailed description

This is a randomized, open label, parallel group study that will be conducted in male and female patients ≥ 40 years of age with bilateral knee OA. Approximately 24 patients will be randomized to one of two treatment groups (1:1) and treated with IA injections to both knees of either: * extended-release FX006 64 mg total dose (approximately 12 patients) or * immediate-release TAcs 80 mg total dose (approximately 12 patients) Each patient will be screened to confirm the diagnosis of OA and eligibility based on the inclusion/exclusion requirements and will be randomized to treatment on Day 1. Following screening, pharmacokinetics (PK) and safety will be evaluated at 6 out-patient visits scheduled on Study Days 1 \[calendar day of injection\], 2, 8, 15, 29, and 43.

Conditions

• Bilateral Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	FX006 32 mg	Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)
DRUG	TAcs 40 mg	Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)

Timeline

• Start date: 2017-12-06
• Primary completion: 2018-03-14
• Completion: 2018-03-14
• First posted: 2017-12-19
• Last updated: 2024-01-24
• Results posted: 2019-05-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study