Clinical Trials Logo
  1. Home
  2. Osteoarthritis of the Knee
  3. NCT02116972

Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

Official title:
A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

Clinical Trial Summary

The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).

Clinical Trial Description

This was a double-blind, randomized, parallel group, dose-ranging, single-dose study. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 300 patients with OA of the knee were randomized, using a centralized randomization procedure, to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of: - 16 mg FX006, - 32 mg FX006, or - normal saline (placebo). Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [Baseline], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll over approximately 6 to 7 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02116972
Study type Interventional
Source Pacira Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 2
Start date April 2014
Completion date November 2015
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Withdrawn NCT02237846 - Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis Phase 1/Phase 2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 NCT02156440 - Cross-over Study of the Efficacy and Safety of SierraSil Joint Formula 14 in Osteoarthritis of the Knee Phase 2
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 NCT01410409 - Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement N/A
Completed NCT01207115 - A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee Phase 2
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 NCT01331278 - A Comparative Study of Knee Systems Phase 4
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