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Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13 per contraction region of large bowel up to fifth times during the colonoscopy.
The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be assessed by an independent committee using recorded video images.
The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0% NPO-13 | Placebo Comparator | Placebo |
|
| 0.2% NPO-13 | Active Comparator | Low dose |
|
| 0.4% NPO-13 | Active Comparator | Medium dose |
|
| 0.8% NPO-13 | Active Comparator | High dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPO-13 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of the splayed region with no contraction after NPO-13 dosage | 3 min |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of the splayed region with an onset of action | 3 min | |
| The proportion of patients with no contraction in all the sprayed regions | 3 min | |
| The proportion of patients with no contraction in one or more the sprayed region |
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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 colonic 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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan | |||||
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 3 min |
| Change in colonic contraction | 3 min |
| Adverse events and ADRs observed between administration and 7 ± 3 days after administration | up to 10 days |
| Osaka |
| Japan |
| Tokyo | Japan |