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Hyalgan

Clinical Pharmacology
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CLINICAL PHARMACOLOGY

Hyalgan

CLINICAL STUDY

The use of Hyalgan® as a treatment for pain in OA of the knee was investigated in a multicenter clinical trial conducted in the United States.

Study Design

This study was a double-masked, placebo and naproxen-controlled, multicenter prospective clinical trial with three treatment arms, as summarized in Table 2. A total of 495 subjects with moderate to severe pain was randomized (at baseline evaluation) into three treatment groups in a ratio of 1:1:1 Hyalgan®, placebo, or naproxen.


TABLE 2. STUDY DESIGN
Routes of
Administration 		Hyalgan® Placebo Naproxen
s.c. Lidocaine (1%) Lidocaine (1%) Lidocaine (1%)
i.a. * Hyalgan® (20 mg/2 mL) Phosphate-Buffered
Saline (2 mL) 		none
p.o./b.i.d. Placebo for naproxen
capsules 		Placebo for naproxen
capsules 		Naproxen capsules
(500 mg)
p.o./p.r.n. (not to exceed
4 grams/day) 		Acetaminophen Acetaminophen Acetaminophen
Legend: s.c. = subcutaneous; i.a. = intra-articular; p.o. = by mouth; b.i.d. = twice a day; p.r.n. = as needed
* Synovial fluid was aspirated (when present) in the Hyalgan® and placebo groups.

Patient Population and Demographics

The demographics of trial participants were comparable across treatment groups with regard to age, sex, race, height, weight, history of osteoarthritis, prior use of NSAIDs, prior physical therapy, and use of assistive devices (refer to Table 3).


TABLE 3
Demographic Characteristics of
All Randomized Subjects
DEMOGRAPHIC
VARIABLE
TREATMENT  
Hyalgan®
N = 164 		Placebo
N = 168 		Naproxen
N = 163 		TOTAL
N = 495
AGE (years):
    Mean
63.5 64.3 63.2 63.7
    SD
10.1 10.0 9.2 9.8
    Range
41-90 44-85 40-80 40-90
Gender [N (%)]:
   Female
99 (60.3) 91 (54.1) 99 (60.7) 289 (58.4)
   Male
65 (39.6) 77 (45.8) 64 (39.3) 206 (41.6)
Race [N (%)]:
   Caucasian
137 (83.6) 135 (80.4) 133 (81.6) 405 (81.8)
   Black
23 (14.0) 32 (19.0) 25 (15.3) 80 (16.2)
   Other
4 (4.2) 1 (1.0) 5 (3.1) 10 (2.0)
Height (cm):
   Mean
167.8 168.6 167.6 168.0
   SD
8.8 10.7 11.9 10.5
   Range
145-190 142-193 102-198 102-198
Weight (kg):
   Mean
88.4 88.1 89.7 88.7
   SD
18.0 18.2 18.4 18.2
   Range
46-139 49-170 45-150 45-170
NSAIDs Use (N, %)
107 (65.2) 117 (69.6) 113 (69.3) 337 (68.1)
Use of Assistive Devices (N, %)
35 (21.3) 34 (20.2) 32 (19.6) 101 (20.4)
Physical Therapy (N, %)
20 (12.2) 17 (10.1) 25 (15.3) 62 (12.5)
Legend: cm = centimeters; kg = kilograms; SD = standard deviation


Evaluation Schedule

Brand Name: Hyalgan
Generic Name: Hyaluronate
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