Hyalgan

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Clinical Pharmacology

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Clinical Pharmacology

Hyalgan

After meeting initial screening requirements NSAID therapy was discontinued. After 2 weeks, all subjects returned for baseline evaluations. The baseline evaluation included assessment of three primary effectiveness criteria; measurement of pain during a 50-foot walk test using a 100 mm Visual Analog Scale (VAS), a categorical assessment (0 = none to 5 = disabled) of pain, as assessed by a masked evaluator, during the 48 hours preceding the visit, and a categorical assessment (0 = none to 5 = disabled) of pain, as assessed by the subject, during the 48 hours preceding the visit.

All subjects who completed the NSAID washout period and met all entry requirements received their first injection after randomization. All subjects received subcutaneous lidocaine injections. Intra-articular injections (Hyalgan®, placebo) were administered weekly for a total of 5 injections (Weeks 0-4). The naproxen group received 500 mg of naproxen to be taken b.i.d. for 26 weeks.

Subsequent visits and evaluations took place at Weeks 5, 9, 12, 16, 21, and 26. Safety and effectiveness criteria were assessed and recorded at these time periods.

Clinical Results

For this trial, overall success for effectiveness was defined as meeting all four of the success criteria listed in Table 4 using scores from week 26. The criteria were met (refer to Tables 4 through 8).

TABLE 4
Clinical Results
Evaluation	Success Criteria	Results
100 mm VAS for pain during 50- foot walk.	A statistically significant (alpha = 0.05) reduction on mean VAS for Hyalgan® when compared to placebo at Week 26. This difference was also to exceed one fourth of the Standard Deviation of the mean change from baseline.	At Week 26, the difference between the Hyalgan®-treated group and the placebo-treated group adjusted means was 8.85 mm (p = 0.0043), which is a difference of approximately one-third of a standard deviation (Table 5).
Masked Evaluator Categorical Assessment of subject pain (0=none to 5=disabled) during the 48 hours preceding visits.	The number of Hyalgan®-treated subjects showing improvement at Week 26 was to be concordant with the VAS results; however, not required to be independently statistically significant.	At Week 26 the masked evaluator's categorical assessment of pain indicated that the Hyalgan®-treated subjects experienced less pain than the placebo-treated subjects (Table 6).
Subjects' Categorical Assessment of pain (0=none to 5=disabled) during the 48 hours preceding visits.	The number of Hyalgan®-treated subjects showing improvement at Week 26 was to be concordant with the VAS results; however, not required to be independently statistically significant.	At Week 26 the subjects' categorical assessment of pain indicated that the Hyalgan®-treated subjects experienced less pain than the placebo-treated subjects (Table 7).
Magnitude of the observed effect for Hyalgan® versus placebo on both the VAS and the categorical pain assessments.	At Week 26 the magnitude of the observed effect for Hyalgan® versus placebo on both the VAS and the categorical pain assessments were to be at least 50% of those observed for the naproxen group.	The improvement in pain on the VAS exhibited by the Hyalgan®-treated group relative to the placebo-treated group were at least 50% of the benefits exhibited by the naproxen-treated group relative to the placebo-treated group. The results of the categorical assessments by the masked evaluator and the subject indicated that improvement of the Hyalgan®-treated group relative to the placebo-treated group was at least 50% of the benefits exhibited by the naproxen-treated group relative to the placebo-treated group (Table 8).