drugset / Trial / NCT04097574

Study of NPO-13 During Colonoscopy

NCT04097574

Phase 2 Completed 158 enrolled Nihon Pharmaceutical Co., Ltd
RandomizedParallel-groupTriple-blindDiagnostic

Summary

This study will investigate the safety, efficacy and dose-response of NPO-13 in subjects with moderate to severe colonic spasm during colonoscopy. An intraluminal spraying of NPO-13 dosed up to twice into ascending or sigmoid colon. The colonic spasm will be assessed by an independent committee using recorded video images. The study consists of a screening visit window, 1-day treatment phase and 1-week follow-up phase.

Timeline

Start
2019-08-26
Primary completion
2020-03-26
Completion
2020-03-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Peppermint oil Other / unclassified 0.8 % Other
Comparator Peppermint oil Other / unclassified 1.6 % Other

Indications