Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPO-13 0.8% | Active Comparator | Low dose |
|
| NPO-13 1.6% | Active Comparator | High dose |
|
| NPO-13 0% | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPO-13: l-menthol | Drug | 20 mL/site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment | The primary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe. | 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment | The secondary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe. | 3 minutes |
| Change in colonic spasm before and after treatment of NPO-13 treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hisatsugu Asada | Nihon Pharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NPO-13 Trial Site 11 | Kitakyushu | Fukuoka | Japan | |||
| NPO-13 Trial Site 12 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The evaluated colonic spasm grades will be converted into a numeric score, and difference between paired mean scores (before and after application, or 0.8% NPO-13, 1.6% NPO-13 and placebo) will be calculated. |
| 3 minutes |
| Time to effect | The onset of anti-spasmodic effect is the interval from the spray to the disappearance of the spasm. | 3 minutes |
| Difficulty of endoscopic observation | The proportion of subjects in whom intracolonic examination will be evaluated by the investigator to be "Very easy" or "Easy"., using a four-grade scale: 1, Very easy; 2, Easy; 3, Difficult; 4, Hard. | 3 minutes |
| Adverse events and Adverse drug reactions | The subjects will be observed for 7 days after colonoscopy, and all adverse events and adverse drug reactions will be recorded and compared with the placebo group. | 7 ± 3 days |
| Kurume |
| Fukuoka |
| Japan |
| NPO-13 Trial Site 2 | Maebashi | Gunma | Japan |
| NPO-13 Trial Site 5 | Yokohama | Kanagawa | Japan |
| NPO-13 Trial Site 6 | Yokohama | Kanagawa | Japan |
| NPO-13 Trial Site 1 | Shimotsuke | Tochigi | Japan |
| NPO-13 Trial Site 4 | Minato | Tokyo | Japan |
| NPO-13 Trial Site 3 | Shinjuku | Tokyo | Japan |
| NPO-13 Trial Site 9 | Hiroshima | Japan |
| NPO-13 Trial Site 13 | Kagoshima | Japan |
| NPO-13 Trial Site 10 | Kochi | Japan |
| NPO-13 Trial Site 7 | Osaka | Japan |
| NPO-13 Trial Site 8 | Osaka | Japan |