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

Bowel Disease Clinical Trial

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02265939
Study type Interventional
Source Nihon Pharmaceutical Co., Ltd
Contact
Status Completed
Phase Phase 2
Start date October 2014
Completion date March 2015
View Details
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