- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487200
Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee
A Double-Blind, Randomized, Parallel Group, Active Comparator Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects (HPA Axis) of FX006 in Patients With Osteoarthritis of the Knee
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was a double-blind, randomized, parallel-group, active comparator design. The study was conducted in male and female patients ≥35 years of age with symptomatic OA of the knee.
Twenty-four (24) patients with knee OA were randomized (1:1:1:1) and treated with a single IA injection of either 10, 40, or 60 mg of FX006 or 40 mg of TCA IR.
Each patient was evaluated for a total of 6 weeks following a single IA injection. Following screening, safety, PK and pharmacodynamics (PD) were evaluated during one (1) 48-hour in-patient period (Day -1 to Day 2), two (2) 24-hour in-patient periods (Day 14-15 and Day 42-43) and seven (7) out-patient visits (Days 3, 4, 5, 8, 22, 29 and 36).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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South Australia
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Adelaide, South Australia, Australia, 5000
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Western Australia
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Perth, Western Australia, Australia
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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 >=35 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
- Body mass index (BMI) ≤ 40 kg/m2
- Willingness to abstain from use of the protocol-specified restricted medications
Main Exclusion Criteria:
- 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 or 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
- History of or active malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ within 5 years
- Insulin-dependent diabetes
- 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 |
---|---|
Experimental: FX006 10mg
Single 3 mL intra-articular (IA) injection Extended-release formulation
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single 3 mL IA injection
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Experimental: FX006 40mg
Single 3 mL intra-articular (IA) injection Extended-release formulation
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single 3 mL IA injection
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Experimental: FX006 60 mg
Single 3 mL intra-articular (IA) injection Extended-release formulation
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single 3 mL IA injection
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Active Comparator: TCA IR (40 mg)
Single 1 mL intra-articular (IA) injection Immediate-release formulation
|
single 1 mL IA injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in 24-hour Weighted Mean Serum Cortisol
Time Frame: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
|
The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol.
This is defined as AUC over the 0-24 hour measurement period divided by 24
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Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
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Characterize the Pharmacokinetic Profile of FX006 and TCA IR
Time Frame: Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43
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Concentrations below the limit of quantification of 50 pg/mL were treated as 0.
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Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in 24-hour Urinary Free Cortisol Excretion
Time Frame: Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)
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Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)
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Total 24-hour Urinary Free Cortisol Excretion
Time Frame: Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
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Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)
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Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol
Time Frame: Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43
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Least square mean difference against TCA IR 40 mg
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Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Neil Bodick, MD, Flexion Therapeutics
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 (Estimated)
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
- FX006-2011-002
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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