Flexeril Clinical Trials and Studies
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Flexeril Clinical Trials and Studies
Controlled clinical Flexeril studies show that cyclobenzaprine HCl significantly improves the signs and symptoms of skeletal muscle spasm as compared with placebo. The clinical responses include improvement in muscle spasm as determined by palpation, reduction in local pain and tenderness, increased range of motion, and less restriction in activities of daily living. When daily observations were made, clinical improvement was observed as early as the first day of therapy.
Eight double-blind controlled clinical studies were performed in 642 patients comparing Flexeril, diazepam, and placebo. Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated. In three of these studies there was a significantly greater improvement with cyclobenzaprine HCl than with diazepam, while in the other studies the improvement following both treatments was comparable.
Although the frequency and severity of adverse reactions observed in patients treated with Flexeril were comparable to those observed in patients treated with diazepam, dry mouth was observed more frequently in patients treated with Flexeril and dizziness more frequently in those treated with diazepam. The incidence of drowsiness, the most frequent adverse reaction, was similar with both drugs.
Analysis of the data from controlled studies shows that cyclobenzaprine HCl produces clinical improvement whether or not sedation occurs.
Surveillance Program
A post-marketing surveillance program was carried out in 7607 patients with acute musculoskeletal disorders, and included 297 patients treated for 30 days or longer. The overall effectiveness of Flexeril was similar to that observed in the double-blind controlled studies; the overall incidence of adverse effects was less.
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