Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of … (NCT03382262) | Clinical Trial Compass
CompletedPhase 2
Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip
United States55 participantsStarted 2017-12-18
Plain-language summary
This is an open-label study to compare systemic exposure to triamcinolone acetonide following a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide suspension) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip
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
* Body mass index (BMI) less than or equal to 40 kg/m2
* 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 treatments from Screening through End-of-Study visit
* Symptoms consistent with OA of the index joint for ≥ 6 months prior to Screening (patient reported is acceptable)
* Pain in the index joint for greater than15 days over the last month (as reported by the patient)
* For Shoulder OA patients: Radiologic findings of OA of the index shoulder meeting the Samilson-Prieto (S-P) Classification Grades 2 or 3
* For Hip OA patients: ACR Criteria (clinical and radiological) for OA of the index hip
Exclusion Criteria:
* Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
* History of infection in the index joint
* Clinical findings consistent with active infection or crystal disease in the index joint within 1 month of Screening
* History of fracture in the index limb within 12 months of Screening, or fracture with sequelae at any time
* Planned or anticipated surgery of the index joint during the study period
* Index joint instability or history of acute dislocation within 12 months of Screening
* If …
What they're measuring
1
Concentration of Triamcinolone Acetonide (TA) in Blood Plasma