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Clinical Trials
U.S. FDA approves further changes to CORTOSS IDE pivotal study protocol
May 18th, 2006
Orthovita, Inc. (VITA), a developer of orthopedic biomaterials, announced that the U.S. Food and Drug Administration (FDA) has approved further changes to the protocol for its CORTOSS IDE pivotal study. The changes include a reduction in the number of total patients to be enrolled from 300 down to 243, as well as an increase in the randomization ratio of patients treated with CORTOSS to patients in the control group treated with an approved PMMA bone cement. The protocol now provides for the enrollment of 162 patients in the CORTOSS arm of the study and 81 patients in the control group, for an overall randomization of 2:1. The prospective randomized...
Source: Biotech Business Week (2006-05-18)
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