Status:
COMPLETED
Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Bilateral Knee Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.
Detailed Description
This is a randomized, open label, parallel group study that will be conducted in male and female patients ≥ 40 years of age with bilateral knee OA. Approximately 24 patients will be randomized to one...
Eligibility Criteria
Inclusion
- Written consent to participate in the study
- Male or female greater than or equal to 40 years of age
- Symptoms consistent with OA in both knees for greater than or equal to 6 months prior to Screening (patient reported is acceptable)
- Currently meets ACR Criteria (clinical and radiological) for OA in both knees
- Knee pain in both knees for greater than 15 days over the last month (as reported by the patient)
- Body mass index (BMI) less than or equal to 40 kg/m2
- Morning serum cortisol result within normal range at Screening (5-23 mcg/dL or 138-635 nmol/dL)
- Ambulatory and in good general health
- Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.
- Willing to abstain from use of protocol-restricted medications during the study
Exclusion
- Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- History of infection in either knee joint
- Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening
- Unstable joint (such as a torn anterior cruciate ligament) in either knee within 12 months of Screening
- Presence of surgical hardware or other foreign body in either knee
- Surgery or arthroscopy of either knee within 12 months of Screening
- IA treatment of any joint with any of the following agents within six (6) months of Screening: any corticosteroid preparation (investigational or marketed, including FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed).
- IA treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
- Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
- Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
- Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03378076
Start Date
December 6 2017
End Date
March 14 2018
Last Update
January 24 2024
Active Locations (3)
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1
LA Biomed at Harbor-UCLA Medical Center
Torrance, California, United States, 90509
2
Rochester Clinical Research
Rochester, New York, United States, 14609
3
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635