NCT02265939

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Nihon Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bowel Disease

Interventions

Type	Name	Description
DRUG	NPO-13

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-10-16
• Last updated: 2021-11-16

Locations

3 sites across 1 country: Japan