Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

Completed · Phase 2

Conditions studied: Bilateral Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT03378076

Run by

Pacira Pharmaceuticals, Inc

People needed

24

Starts

2017-12-06

Expected to finish

2018-03-14

Last updated by the study team

2024-01-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• LA Biomed at Harbor-UCLA Medical Center — Torrance, California, United States
• Rochester Clinical Research — Rochester, New York, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.