Study of NPO-13 During Colonoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of NPO-13 in Patients Undergoing Colonoscopy

Conditions
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Bowel Disease

Intervention / Treatment
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* Drug: NPO-13: l-menthol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are between 20 and 85 years at the time of consent Patients who need colonoscopy Exclusion Criteria: Patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation Patients with contraindication to colonoscopy including the paralytic ileus Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil) Patient with contraindication to bowel cleansing preparation Patient with contraindication to pain medicine and sedative medicine Patient with contraindication to butylscopolamine bromide and glucagon Patients on cancer treatment (chemotherapy or radiotherapy) Patient with active inflammatory bowel disease or infectious enteritis Patients who need sedative in colonoscopy Patients who receives a therapeutic colonoscopy Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies Patients otherwise ineligible for participation in the study in the investigator's or coinvestigator's opinion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NPO-13 0.8%<br>Low dose | Drug: NPO-13: l-menthol<br>* 20 mL/site<br>|
| Active Comparator: NPO-13 1.6%<br>High dose | Drug: NPO-13: l-menthol<br>* 20 mL/site<br>|
| Placebo Comparator: NPO-13 0%<br>Placebo | Drug: NPO-13: l-menthol<br>* 20 mL/site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |