Table 1.
Schedule of observations and procedures
| Procedure | Visit 1 Screening | Visit 2 Day 0 | Visit 3 Day 30 | Visit 4 Day 60 | Visit 5 Day 90 |
|---|---|---|---|---|---|
| Informed consent | X | ||||
| Review inclusion/exclusion | X | X | X | X | X |
| Medical history including activity level and diet history | X | ||||
| Physical examination | X | ||||
| Biometric measurements: Weight, height*, heart rate and blood pressure. | X | X | X | X | X |
| Urine pregnancy test | X | ||||
| Concomitant medications | X | X | X | X | X |
| Blood samples: Uric acid, CBC count and differentiation, albumin, total protein, sodium, potassium, chloride, BUN, creatinine, ALT, AST, bilirubin, ESR, rheumatoid factor | X | X | |||
| WOMAC, VAS and Lequesne scores | X | X | X | X | X |
| X-ray | X | ||||
| Randomization | X | ||||
| Blood sample: ALT, AST, bilirubin, albumin. | X† | X† | |||
| Knee flexion, Time to walk 50m, Swelling in the knee joint, Time for climbing 10 steps | X | X | X | X | |
| Physician's Global Assessment | X | X | X | X | |
| Subject's Global Assessment | X | X | X | X | |
| Investigational Product dispensed | X | X | X | ||
| Subject Treatment Diary dispensed | X | X | X | ||
| Investigational Product returned Compliance calculated | X | X | X | ||
| Subject Treatment Diary returned | X | X | X | ||
| Adverse Events | X | X | X |
* height was only measured at visit 1
† If acetaminophen use was greater than 2 g/day for more than 7 days