Study of FX006 in Patients With Osteoarthritis of the Knee

NCT ID: NCT01487161

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-04-30

Brief Summary

The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.

Detailed Description

Study FX006-2011-001 was a multi-center, randomized, double-blind, active comparator, parallel-group, single-dose study designed to assess the magnitude and duration of pain relief of three doses (10, 40, and 60 mg) of FX006, an extended-release formulation of TCA, relative to commercially-available TCA IR.

The general tolerability of a single injection of FX006 also was assessed.

Secondary objectives included exploration of the effect of FX006 on functional improvement, responder status, time to onset of pain relief, global impressions of change, and consumption of analgesic medications and evaluation of the PK profile of single injection of the three dose levels of FX006.

The study was planned to be conducted in up to 224 male and female patients ≥40 years of age with OA of the knee enrolled at 22 study centers in the US, Australia, and Canada.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FX006 10 mg

Single 3 mL intra-articular (IA) injection Extended-Release Formulation

Group Type: EXPERIMENTAL

FX006

Intervention Type: DRUG

Single 3 mL intra-articular injection

FX006 40 mg

Single 3 mL intra-articular (IA) injection Extended-Release Formulation

Group Type: EXPERIMENTAL

FX006

Intervention Type: DRUG

Single 3 mL intra-articular injection

FX006 60 mg

Single 3mL intra-articular (IA) injection Extended-Release Formulation

Group Type: EXPERIMENTAL

FX006

Intervention Type: DRUG

Single 3 mL intra-articular injection

TCA IR 40 mg

Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide

Group Type: ACTIVE_COMPARATOR

TCA IR

Intervention Type: DRUG

Single 1 mL intra-articular injection

Interventions

FX006

Single 3 mL intra-articular injection

Intervention Type: DRUG

TCA IR

Single 1 mL intra-articular injection

Intervention Type: DRUG

Other Intervention Names

Kenalog®-40 Injection; Kenacort-A 40; Triamcinolone Acetonide Crystalline Suspension (TAcs)

Eligibility Criteria

Inclusion Criteria

• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
• Male or female >=40 years of age
• Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
• Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
• Body mass index (BMI) ≤ 40 kg/m2
• Willingness to abstain from use of restricted medications

Exclusion Criteria

• Ipsilateral hip OA
• Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
• History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
• History of arthritides due to crystals (e.g., gout, pseudogout)
• History of infection in the index joint
• Clinical signs and symptoms of active knee infection or crystal disease of the index knee
• Presence of surgical hardware or other foreign body in the index knee
• Unstable joint (such as a torn anterior cruciate ligament)
• IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
• IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
• Oral, inhaled and intranasal corticosteroids (investigational or marketed) within 1 month 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
• Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
• Insulin-dependent diabetes
• Active psychiatric disorder including psychosis and major depressive disorder
• History of or active Cushing's syndrome
• Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
• Skin breakdown at the knee where the injection would take place
• Women of child-bearing potential not using effective contraception or who are pregnant or nursing

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Bodick, MD, PhD

Role: STUDY_DIRECTOR

Flexion Therapeutics

Locations

Tucson, Arizona, United States

Duncansville, Pennsylvania, United States

Broadmeadow, New South Wales, Australia

Kogarah, New South Wales, Australia

St Leonards, New South Wales, Australia

Wollongong, New South Wales, Australia

Kippa-Ring, Queensland, Australia

Maroochydore, Queensland, Australia

Sherwood, Queensland, Australia

Clayton, Victoria, Australia

Malvern East, Victoria, Australia

Halifax, Nova Scotia, Canada

Etobicoke, Ontario, Canada

Newmarket, Ontario, Canada

Saint Catherine's, Ontario, Canada

Sarnia, Ontario, Canada

Thornhill, Ontario, Canada

Waterloo, Ontario, Canada

Windsor, Ontario, Canada

Montreal, Quebec, Canada

Sainte-Foy, Quebec, Canada

Countries

United States; Australia; Canada

Related Links

http://journals.lww.com/jbjsjournal/Abstract/2015/06030/An_Intra_Articular,_Extended_Release_Formulation.1.aspx

Journal of Bone \& Joint Surgery - American Volume: 3 June 2015 - Volume 97 - Issue 11 - p 877-888

Other Identifiers

FX006-2011-001

Identifier Type: -

Identifier Source: org_study_id