drugset / Trial / NCT04097574
Study of NPO-13 During Colonoscopy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Peppermint oil | Other / unclassified | 0.8 % | Other |
| Comparator | Peppermint oil | Other / unclassified | 1.6 % | Other |