- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487161
Study of FX006 in Patients With Osteoarthritis of the Knee
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New South Wales
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Broadmeadow, New South Wales, Australia
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Kogarah, New South Wales, Australia
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St. Leonards, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Queensland
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Kippa-Ring, Queensland, Australia
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Maroochydore, Queensland, Australia
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Sherwood, Queensland, Australia
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Victoria
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Clayton, Victoria, Australia
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Malvern East, Victoria, Australia
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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Etobicoke, Ontario, Canada
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Newmarket, Ontario, Canada
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Sarnia, Ontario, Canada
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St. Catherine's, Ontario, Canada
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Thornhill, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Arizona
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Tucson, Arizona, United States, 85704
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: FX006 10 mg
Single 3 mL intra-articular (IA) injection Extended-Release Formulation
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Single 3 mL intra-articular injection
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Experimental: FX006 40 mg
Single 3 mL intra-articular (IA) injection Extended-Release Formulation
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Single 3 mL intra-articular injection
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Experimental: FX006 60 mg
Single 3mL intra-articular (IA) injection Extended-Release Formulation
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Single 3 mL intra-articular injection
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Active Comparator: TCA IR 40 mg
Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide
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Single 1 mL intra-articular injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 8 weeks
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The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
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8 weeks
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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
Time Frame: 10 weeks
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The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
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10 weeks
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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
Time Frame: 12 weeks
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The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
Time Frame: Weeks 8, 10 and 12
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The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
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Weeks 8, 10 and 12
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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.
Time Frame: Weeks 1-7 and Week 9 and 11
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The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
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Weeks 1-7 and Week 9 and 11
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WOMAC A (Pain Subscale) Change From Baseline at Week 8
Time Frame: 8 weeks
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The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale.
The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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8 weeks
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WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8
Time Frame: 8 weeks
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The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale.
The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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8 weeks
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WOMAC B (Stiffness Subscale) Change From Baseline at Week 8
Time Frame: 8 weeks
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The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale.
The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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8 weeks
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WOMAC C (Function Subscale) Change From Baseline at Week 8
Time Frame: 8 weeks
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The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale.
The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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8 weeks
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Percent of Responders According to OMERACT-OARSI Criteria at Week 8
Time Frame: 8 weeks
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Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International.
Responders are defined as participants with high improvement in pain or function.
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8 weeks
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Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
Time Frame: 8 weeks
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The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
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8 weeks
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Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
Time Frame: 8 weeks
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The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
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8 weeks
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Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8
Time Frame: 8 weeks
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The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine."
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8 weeks
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Patient Global Impression of Change Scores at Week 8
Time Frame: Week 8
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The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not.
The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status).
This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse).
Lower scores indicate better health status.
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Week 8
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Clinical Global Impression of Change Scores at Week 8
Time Frame: 8 weeks
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The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not.
The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status).
This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse).
Lower scores indicate better health status.
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8 weeks
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Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.
Time Frame: 8 weeks
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Neil Bodick, MD, PhD, Flexion Therapeutics
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
- FX006
Other Study ID Numbers
- FX006-2011-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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