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Pilot Study Shows Benefit of Hyalgan to Treat Osteoarthritis of the Ankle

February 25, 2005

Sanofi-Synthelabo, a member of the sanofi-aventis Group, has announced results of a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of Hyalgan versus saline, in the treatment of osteoarthritis (OA) of the ankle.

The data from this pilot study suggested that five weekly intra-articular injections of Hyalgan (sodium hyaluronate) provide sustained relief of pain and improved ankle function in patients suffering from OA of the ankle.

The trial, "Use of Sodium Hyaluronate in Treating Osteoarthritis of the Ankle," conducted as an investigator-initiated study by researchers from the Northern California Foot and Ankle Center in San Francisco and Santa Rosa, Calif., showed a statistically significant time effect in mean ankle osteoarthritis scale scores in both the Hyalgan and saline group. Researchers also reported that 55.6 percent of the patients treated with Hyalgan had a clinically significant improvement in their visual analog scales scores compared to a 12.5 percent improvement in the saline group.

The Northern California Foot and Ankle Center trial is the first controlled study to show a benefit with Hyalgan in treatment of OA of the ankle and is consistent with previously published studies using Hyalgan in the knee, the company said.