Bowel Disease
Conditions
Brief summary
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.
Interventions
DRUGNPO-13: l-menthol
20 mL/site
Sponsors
Nihon Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are between 20 and 85 years at the time of consent 2. Patients who need colonoscopy
Exclusion criteria
1. Patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation 2. Patients with contraindication to colonoscopy including the paralytic ileus 3. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil) 4. Patient with contraindication to bowel cleansing preparation 5. Patient with contraindication to pain medicine and sedative medicine 6. Patient with contraindication to butylscopolamine bromide and glucagon 7. Patients on cancer treatment (chemotherapy or radiotherapy) 8. Patient with active inflammatory bowel disease or infectious enteritis 9. Patients who need sedative in colonoscopy 10. Patients who receives a therapeutic colonoscopy 11. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study 12. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies 13. Patients otherwise ineligible for participation in the study in the investigator's or coinvestigator's opinion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment | 3 minutes | The primary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment | 3 minutes | The secondary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe. |
| Change in colonic spasm before and after treatment of NPO-13 treatment | 3 minutes | 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. |
| Time to effect | 3 minutes | The onset of anti-spasmodic effect is the interval from the spray to the disappearance of the spasm. |
| Difficulty of endoscopic observation | 3 minutes | 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. |
| Adverse events and Adverse drug reactions | 7 ± 3 days | 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. |
Countries
Japan
Outcome results
None listed