The Phase II multi-center, double-blind, placebo-controlled trial will be conducted in the US and will evaluate the analgesic efficacy and safety of intravenous CR845 during the post-operative period in women following laparoscopic-assisted hysterectomy.
The trial is expected to enroll 120 patients, who will be randomly selected for treatment with one of two doses of CR845 or placebo. Results from the study are expected in the second half of 2009.
The company also expects to initiate a Phase I study of an oral formulation of CR845 later in 2009.