Trials / Completed
CompletedNCT03263910
Study of NPO-11 in Patients Undergoing Gastrointestinal Endoscopy
Phase Ⅲ Placebo-controlled Study of NPO-11 in Chinese Patients Undergoing Gastrointestinal Endoscopy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- Nihon Pharmaceutical Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Chinese patients who require gastrointestinal endoscopy will receive an intra-gastric single dose of NPO-11 20ml. The superiority of NPO-11 compared to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients having no gastric peristalsis. The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions observed between informed consent and 7 days after administration in comparison with the placebo group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NPO-11 | 20 ml NPO-11 |
| DRUG | Placebo | 20 ml NPO-11(Placebo) |
Timeline
- Start date
- 2017-08-21
- Primary completion
- 2018-08-10
- Completion
- 2018-08-17
- First posted
- 2017-08-28
- Last updated
- 2018-08-23
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03263910. Inclusion in this directory is not an endorsement.