Trials / Completed
CompletedNCT04097574
Study of NPO-13 During Colonoscopy
Phase II Study of NPO-13 in Patients Undergoing Colonoscopy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Nihon Pharmaceutical Co., Ltd · Industry
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NPO-13: l-menthol | 20 mL/site |
Timeline
- Start date
- 2019-08-26
- Primary completion
- 2020-03-26
- Completion
- 2020-03-26
- First posted
- 2019-09-20
- Last updated
- 2020-08-17
Locations
13 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04097574. Inclusion in this directory is not an endorsement.