NCT01291914

Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

A Double-Blind, Randomized,Placebo-Controlled, Two-Phase Study (a Single Ascending Dose Phase Followed by a Proof of Concept Phase) to Assess the Safety, Efficacy and Pharmacokinetics of FX005 for the Treatment of Pain in Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.

Detailed description

The objectives of the study are to assess FX005, as compared to placebo control, for: * Safety and tolerability * Analgesic effect * Pharmacokinetics Analgesic effect will be assessed using the Western Ontario \& McMaster University Osteoarthritis Index (WOMAC), the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, and patient and clinical observer global assessments.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	FX005	Single Ascending Dose (SAD) Phase Cohorts: 1, 10 or 45 mg intra-articular injection; Proof of Concept Phase: Maximum, well-tolerated dose intra-articular injection (determined during SAD Phase)
DRUG	Placebo 1 (Carrier)	Single intra-articular injection
DRUG	Placebo 2 (Diluent)	Single intra-articular injection

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-01-01
• Completion: 2012-03-01
• First posted: 2011-02-09
• Last updated: 2024-01-24

Locations

13 sites across 4 countries: Austria, Canada, Spain, United Kingdom