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

Osteoarthritis of the Knee Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02003365
Study type Interventional
Source Pacira Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 2
Start date November 2013
Completion date April 2014
View Details
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