NCT02003365

Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee

An Open-label, Single Administration Study to Characterize the Local Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis (OA) of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

Detailed description

This study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with OA of the knee. Patients were enrolled sequentially with 8 patients per cohort, as follows: Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16 Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12 Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12 Each patient was evaluated for up to 12, 16, or 20 weeks following a single IA injection depending on the assigned cohort. Following the screening visit, safety was evaluated at 3 out-patient visits and synovial fluid was collected at Day 1 for baseline measurements and the Final Visit for drug concentration measurements.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	FX006 10 mg	Extended-release formulation
DRUG	FX006 40 mg	Extended-release formulation
DRUG	TCA IR 40 mg	Immediate-release formulation

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-12-06
• Last updated: 2024-01-24
• Results posted: 2018-01-12

Locations

3 sites across 1 country: United States