Phase Ⅱ Dose Response Study of NPO-13 in Patients Undergoing Total Colonoscopy

Summary

Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13 per contraction region of large bowel up to fifth times during the colonoscopy. The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be assessed by an independent committee using recorded video images. The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.

Timeline

Start

2014-10

Primary completion

2015-03

Completion

2015-03

Drugs

Indications