Gel-200 Versus Placebo in Osteoarthritis of the Knee

Плацебо Компаратор: PBS

Устройство: Placebo

Single intra-articular injection

Экспериментальный: Gel-200

Устройство: Gel-200

Single intra-articular injection

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore

Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

Change From Baseline in WOMAC VAS Stiffness Subscore

Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

Change From Baseline in WOMAC VAS Physical Function Subscore

Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

Change From Baseline in WOMAC VAS Total Score

Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response

Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by changes from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).

Change From Baseline in Short Form - 36 (SF-36)

Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10.

Change From Baseline in Subject Global Evaluations

Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

Change From Baseline in Physician Global Evaluations

Observed physician global evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

Acetaminophen Consumption

Weekly mean acetaminophen consumption between weeks 9 and 13.