Connect with LRI:
Facebook
Twitter
YouTube
Change.org

Lupus Clinical Trials

New Medical Therapies™

Otitis Media

March 12, 2007

Replidyne announced positive results from a phase II trial of Orapem for the treatment of acute otitis media in pediatrics. This randomized double-blind trial enrolled 300 pediatric subjects in Costa Rica and Israel. Treatment was administered orally, twice daily in one of four doses. Orapem was well tolerated across all dose levels. The trial met the primary endpoint, eradicating pathogens from the middle ear. In addition, an optimal dose for phase III trials was determined. Based on the results, Replidyne plans to meet with the FDA in order to discuss a phase III trial design.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.