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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Drug: FX005; Drug: Placebo 1 (Carrier); Drug: Placebo 2 (Diluent)

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
  • Wien, Austria
• Canada
  • British Columbia
    • Penticton, British Columbia, Canada
  • Ontario
    • Newmarket, Ontario, Canada
    • Toronto, Ontario, Canada
    • Windsor, Ontario, Canada
  • Quebec
    • Sainte-Foy, Quebec, Canada
• Spain
  • A Coruna, Spain
  • Barcelona, Spain
  • Sevilla, Spain
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain
  • Cantabria
    • Santander, Cantabria, Spain
• United Kingdom
  • Southampton, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female ≥40 years of age
• Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological)
• Kellgren-Lawrence grades II or III
• Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee
• Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee
• Body mass index ≤ 40 kg/m2
• Willingness to abstain from use of restricted medications during the study
• Willingness and ability to comply with the study procedures and visit schedule

Exclusion Criteria:

• Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee
• Clinically apparent tense effusion in index knee
• Presence of surgical hardware or other foreign body in the index knee
• Clinical signs and symptoms of active knee infection or crystal disease
• Intra-articular corticosteroid within 3 months of Screening
• Intra-articular hyaluronic acid within 6 months of Screening
• Other intra-articular therapy within 3 months of Screening
• Prior arthroscopic or open surgery of the index knee within 12 months of Screening
• Planned/anticipated surgery of the index knee during the study period
• History of malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness
• Skin breakdown at the knee where the injection would take place
• Women who are pregnant, nursing or likely to become pregnant during the time of the study
• Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FX005	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)
Placebo Comparator: Placebo 1 (Carrier)	Drug: Placebo 1 (Carrier); Single intra-articular injection
Placebo Comparator: Placebo 2 (Diluent)	Drug: Placebo 2 (Diluent); Single intra-articular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the WOMAC A score (pain subscale)	at 4 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in WOMAC A score (pain subscale)	over 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A score (pain subscale)	at 2, 8 and 12 weeks post treatment
Change from baseline for WOMAC B score (stiffness subscale)	at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC C score (function subscale)	at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A1 response (pain on walking)	at 2, 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC A1 response (pain on walking)	over 4, 8 and 12 weeks post treatment
Change from baseline for WOMAC total score	at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP intermittent pain score	at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP constant pain score	at 2, 4, 8 and 12 weeks post treatment
Change from baseline for ICOAP total score	at 2, 4, 8 and 12 weeks post treatment
Percent of responders according to the OMERACT-OARSI (Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International) criteria	at 4, 8 and 12 weeks post treatment
Change in patient's global assessment score	at 4, 8 and 12 weeks post treatment
Change in clinical observer's global assessment score	at 4, 8 and 12 weeks post treatment
Average weekly consumption of analgesic medications	over 12 weeks post treatment
Incidence of treatment emergent adverse events	up to 12 weeks post treatment

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc
• Investigators: Study Director: Neil Bodick, MD, PhD, Pacira Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 7, 2011
• First Posted (Estimated): February 9, 2011

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis; pain; safety; pharmacokinetics; knee; efficacy; intra-articular
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: FX005-2010-001