Clinical trial NCT01487161: Study of FX006 in Patients With Osteoarthritis of the Knee
Official title: A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis
knee
pain
corticosteroid
intra-articular
injection
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 229
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Main 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

Main 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

Primary outcomes:
measure: Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
timeFrame: 8 weeks
measure: Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
timeFrame: 10 weeks
measure: Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg
timeFrame: Weeks 8, 10 and 12
measure: Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.
timeFrame: Weeks 1-7 and Week 9 and 11
measure: WOMAC A (Pain Subscale) Change From Baseline at Week 8
timeFrame: 8 weeks
measure: WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8
timeFrame: 8 weeks
measure: WOMAC B (Stiffness Subscale) Change From Baseline at Week 8
timeFrame: 8 weeks
measure: WOMAC C (Function Subscale) Change From Baseline at Week 8
timeFrame: 8 weeks
measure: Percent of Responders According to OMERACT-OARSI Criteria at Week 8
timeFrame: 8 weeks
measure: Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
timeFrame: 8 weeks
measure: Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
timeFrame: 8 weeks
measure: Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
timeFrame: 8 weeks
measure: Patient Global Impression of Change Scores at Week 8
timeFrame: Week 8
measure: Clinical Global Impression of Change Scores at Week 8
timeFrame: 8 weeks
measure: Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Duncansville
country: United States
state: Pennsylvania
city: Broadmeadow
country: Australia
state: New South Wales
city: Kogarah
country: Australia
state: New South Wales
city: St. Leonards
country: Australia
state: New South Wales
city: Wollongong
country: Australia
state: New South Wales
city: Kippa-Ring
country: Australia
state: Queensland
city: Maroochydore
country: Australia
state: Queensland
city: Sherwood
country: Australia
state: Queensland
city: Clayton
country: Australia
state: Victoria
city: Malvern East
country: Australia
state: Victoria
city: Halifax
country: Canada
state: Nova Scotia
city: Etobicoke
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: St. Catherine's
country: Canada
state: Ontario
city: Thornhill
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
Study officials:
affiliation: Flexion Therapeutics
name: Neil Bodick, MD, PhD
role: STUDY_DIRECTOR
References: