drugset / Trial / NCT02637323

Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee

NCT02637323

Phase 2 Completed 81 enrolled Pacira Pharmaceuticals, Inc
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

Timeline

Start
2015-11
Primary completion
2016-09
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Triamcinolone Acetonide Other / unclassified 32 mg Other
Subject Triamcinolone Acetonide Other / unclassified 40 mg Other

Indications