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Hyalgan

Clinical Pharmacology
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Clinical Pharmacology

Hyalgan

 

TABLE 7
Subjects' Categorical Assessments of Pain
for Completed Subjects in Prior 48 Hours:
Level of Pain by Treatment Group
at Baseline and Week 26
 
 NUMBER (%) OF SUBJECTS IN CATEGORY
 
 Hyalgan® Placebo Naproxen
 
 Baseline Week 26 Baseline Week 26 Baseline Week 26
None (0)
1 (1.0) 23 (21.9) 0 (0.0) 14 (12.2) 0 (0.0) 13 (11.5)
Slight (1)
2 (1.9) 27 (25.7) 0 (0.0) 24 (20.9) 1 (0.9) 31 (27.4)
Mild (2)
6 (5.7) 19 (18.1) 8 (7.0) 24 (20.9) 7 (6.2) 26 (23.0)
Moderate (3)
62 (59.0) 26 (24.8) 78 (67.8) 40 (34.8) 72 (63.7) 31 (27.4)
Marked (4)
34 (32.4) 10 (9.5) 29 (25.2) 13 (11.3) 33 (29.2) 12 (10.6)
TOTAL
105 (100) 105 (100) 115 (100) 115 (100) 113 (100) 113 (100)

TABLE 8
Hyalgan® Effect as a Percentage of the Naproxen-Placebo Difference
Assessment
Hyalgan®
(HYL) 		Placebo
(PLA) 		Naproxen
(NAP) 		HYL-PLA NAP-HYL NAP-PLA (HYL-PLA)
% of
(NAP-PLA)
VAS for 50 foot
Walk
Baseline Adjusted
Mean Effect
Sizes From
ANCOVA
      -8.85 mm
on a 100 mm
VAS 		4.12 mm
on a 100 mm
VAS 		-4.73 * mm
on a 100 mm
VAS 		187%
  
  
% of Subjects
Improved by
Masked Evaluators
78.1 69.6 73.2 8.5 -4.9 3.6 236%
% of Subjects
Improved
by Subjects
73.3 62.6 67.3 10.7 -6.0 4.7 228%
*Imputed as (NAP-HYL) + (HYL-PLA).
Note that Effectiveness Success Criterion D is satisfied since ((HYL-PLA) % of (NAP-PLA))>50% for all three of the above pain assessments.


Additional Analyses

Brand Name: Hyalgan
Generic Name: Hyaluronate

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