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Patients who require gastric endoscopy will receive an intragastric single dose of NPO-11 20 mL. The superiority of NPO-11 to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary outcome measure).
The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration in comparison with the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N | Active Comparator |
| |
| P | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPO-11 | Drug | 20 ml NPO-11 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of gastric peristalsis (central evaluation by independent evaluator) No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy. | each evaluation point |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gastric peristalsis | each evaluation point | |
| Difficulty level of intragastric observation (evaluation by investigator who performs endoscopy) | each evaluation point | |
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Inclusion Criteria:
Inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected upper gastrointestinal disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study. The criteria (2) to (5) will be confirmed during endoscopy. Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21353674 | Derived | Hiki N, Kaminishi M, Yasuda K, Uedo N, Honjo H, Matsuhashi N, Hiratsuka T, Sekine C, Nomura S, Yahagi N, Tajiri H, Suzuki H. Antiperistaltic effect and safety of L-menthol sprayed on the gastric mucosa for upper GI endoscopy: a phase III, multicenter, randomized, double-blind, placebo-controlled study. Gastrointest Endosc. 2011 May;73(5):932-41. doi: 10.1016/j.gie.2010.12.013. Epub 2011 Feb 26. |
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| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Drug |
20 ml NPO-11(Placebo) |
|
| Adverse events and ADRs observed between administration and 7±3 days after administration |
| each evaluation point |
| Kanto |
| Japan |