Colon Cancer Screening

October 31, 2016

PAION issued results of a phase III trial of remimazolam compared to placebo (with midazolam rescue) in patients undergoing proceduralist-administered sedation for colonoscopy. The trial enrolled a total of 461 patients at 13 U.S. sites. The primary outcome measure was a composite endpoint defined as no need for rescue medication, completion of the procedure and no more than five top-up doses within any 15-minute window. The primary endpoint was reached in 91.3% of the patients in the remimazolam arm and 1.7% in the placebo (including midazolam rescue) arm. Important secondary endpoints in the remimazolam arm showed a median time from start of medication to start of procedure of four minutes (placebo 19.5 minutes) and a mean time from end of procedure to return to full alertness of 7.2 minutes (placebo 21.3 minutes). Additionally, time to “back to normal” as reported by patients on remimazolam was 331 minutes (placebo 572 minutes).

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