Clinical Trials Logo
  1. Home
  2. Osteoarthritis of the Knee
  3. NCT02637323

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

Osteoarthritis of the Knee Clinical Trial

Official title:
An Open-label, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee

Clinical Trial 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.

Clinical Trial Description

This study employed an open-label, single administration design and was conducted in male and female patients ≥40 years of age with OA of the knee. Patients were enrolled sequentially with at least 10 patients per cohort as follows: Cohort A: FX006 32 mg, Final Visit at Week 20 Cohort B: FX006 32 mg, Final Visit at Week 16 Cohort C: FX006 32 mg, Final Visit at Week 12 Cohort D: FX006 32 mg, Final Visit at Week 6 Cohort E: FX006 32 mg, Final Visit at Week 1 Cohort F: TCA IR 40 mg, Final Visit Week 6 Each patient was screened to confirm eligibility and assigned to a cohort on Day 1/baseline. Each patient was evaluated for safety during his/her participation in the study at 6, 12, 16, or 20 weeks following a single IA injection depending on the assigned Cohort, and plasma and synovial fluid was collected for drug concentration measurements. Safety and tolerability was assessed by physical examinations, index knee examinations, vital signs, clinical laboratory evaluations, and adverse events (AEs). No efficacy assessments were employed in this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02637323
Study type Interventional
Source Pacira Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 2
Start date November 2015
Completion date September 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT03277066 - A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis Phase 2
Recruiting NCT03090698 - Outcomes of Injections in Patients Waiting for Total Knee Replacement Phase 4
Completed NCT02556710 - A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee Phase 3
Withdrawn NCT02237846 - Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis Phase 1/Phase 2
Completed NCT02242435 - A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis Phase 3
Completed NCT01849445 - Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study N/A
Completed NCT02096393 - Patient Specific Instrumentation in TKR N/A
Completed NCT01704157 - A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device N/A
Active, not recruiting NCT01374230 - Long-Term Multicenter Evaluation of the E1® Tibial Bearing N/A
Completed NCT01410409 - Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement N/A
Not yet recruiting NCT01270412 - Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis Phase 2/Phase 3
Completed NCT02156440 - Cross-over Study of the Efficacy and Safety of SierraSil Joint Formula 14 in Osteoarthritis of the Knee Phase 2
Completed NCT01207115 - A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee Phase 2
Completed NCT01331278 - A Comparative Study of Knee Systems Phase 4
Completed NCT00988091 - Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee Phase 3
Completed NCT00970008 - Exploring Massage Benefits for Arthritis of the Knee Phase 2
Completed NCT00531427 - Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee Phase 3
Completed NCT00792727 - HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain Phase 3
Completed NCT00449696 - Gel-200 Versus Placebo in Osteoarthritis of the Knee Phase 3
Completed NCT04145011 - Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain N/A