IDMC recommends continuation of Cara’s Phase III of IV CR845 in postoperative pain
Cara Therapeutics Inc. (NASDAQ:CARA) said an IDMC recommended continuation of the Phase III CLIN3001 trial evaluating 0.5 and 1 μg/kg IV CR845 to treat acute postoperative pain following abdominal surgery. The recommendation was based on a review of safety data, including serum sodium levels. The company said it plans to complete enrollment later this year.
The double-blind, placebo-controlled, U.S. trial’s primary endpoint is change in pain intensity over the 24-hour postoperative period (AUC-24) using the patient-reported Numeric Rating Scale (NRS) score collected at prespecified time points through 24 hours. Secondary endpoints include postoperative nausea and vomiting...
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