Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With… (NCT03378076) | Clinical Trial Compass
CompletedPhase 2
Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA
United States24 participantsStarted 2017-12-06
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 …
What they're measuring
1
Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma