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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPO-11 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPO-11 | Drug | 20 ml NPO-11 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients had no gastric peristalsis during the procedures | No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy.(central evaluation by independent evaluator) | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peristaltic movement | The measure use peristaltic grade(central evaluation by independent evaluator). | 15 minutes |
| Difficulty level of intra-gastric observation | Subjective evaluation by investigator or subinvestigator who performs endoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East China | East China | China | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33527576 | Derived | Meng F, Li W, Zhi F, Li Z, Xue Z, He S, Chen W, Chen Y, Xing X, Yao C, Wu Y, Zhang S. Antiperistaltic effect and safety of l-menthol oral solution on gastric mucosa for upper gastrointestinal endoscopy in Chinese patients: Phase III, multicenter, randomized, double-blind, placebo-controlled study. Dig Endosc. 2021 Nov;33(7):1110-1119. doi: 10.1111/den.13941. Epub 2021 Apr 2. |
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| Drug |
20 ml NPO-11(Placebo) |
|
| 15 minutes |
| Correlation between the time from the dose to the end of endoscopy and peristaltic grade | 15 minutes |
| North China |
| China |
| Northwest China | China |
| South China | China |