Procedures common to both protocols | Screening (Visit 1) | Study period | ||
---|---|---|---|---|
Day 1 (Baseline Visit 2) | Days 7, 30, 60, 90, 120, 150 (Visits 3, 4, 5, 6, 7, 8) | Day 180 (Visit 9) | ||
Signed Informed Consent | X | |||
Inclusion/Exclusion Reviewed | X | X | X | |
Medical/Surgical/Medication History | X | |||
Physical Examination | X | |||
Vital Signs | X | X | X | X |
Heighta, Weight, BMI | X | X | ||
Clinical Assessment for Knee Pain & Swelling | X | X | X | X |
Knee Flexion Range of Motion | X | X | X | |
X-ray examination | X | |||
WOMAC Score | X | X | X | X |
VAS Scale | X | X | X | X |
LFI Score | X | X | X | X |
Clinical Laboratory Tests (hematology, chemistry, urinalysis) | X | X | ||
Urine Pregnancy Test (if applicable) | X | X | X | |
Serum biomarker analysis-COMP | X | X | ||
Randomization Number Assigned | X | |||
Investigational Product Administration | X | |||
Dispense Subject Diary | X | X | ||
Collect/Review Subject Diary | X | X | ||
Provide Directions for Concomitant Medication and Rescue Medication Use | X | X | X | |
Dispense New Investigational Product | X | X | ||
Review Product Accountability | X | X | ||
Assess use of Concomitant Medications | X | X | X | |
Adverse Events Assessed | X | X | X | |
Procedures Confined to Protocol 003348 | ||||
Synovial fluid biomarker—MMP-3 and IL-6 | X | X | ||
Serum biomarker analysis—CRP | X | X |