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May 6, 2014
07:15 EDTBDSIBioDelivery Sciences randomized half the patients required for Clonidine study
BioDelivery Sciences International announced that it has randomized more than half of the planned number of patients required for its ongoing initial Phase 3 study of Clonidine Topical Gel, BDSI's proposed treatment for painful diabetic neuropathy. The intent of the study will be to demonstrate the efficacy and safety of Clonidine Topical Gel for the treatment of PDN. An interim analysis of the study, which will be based on the first 50% of patients entering the study, is now anticipated to occur in the Q3 of 2014. It was earlier projected based on estimated patient enrollment the interim analysis would occur in fourth quarter of this year. The purpose of the interim analysis is to confirm the assumptions regarding the study sample size and allow for an increase if needed.
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