Study of NPO-13 During Colonoscopy

Bowel Disease Clinical Trial

Official title:

Phase II Study of NPO-13 in Patients Undergoing Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097574
• Other study ID #: NPO-13-01/ED-01
• Status: Completed
• Phase: Phase 2
• Start date: August 26, 2019
• Est. completion date: March 26, 2020

Study information

• Verified date: August 2020
• Source: Nihon Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Disease
• Intestinal Diseases

Intervention

Drug:
• NPO-13: l-menthol
20 mL/site

Locations

Country	Name	City	State
Japan	NPO-13 Trial Site 9	Hiroshima
Japan	NPO-13 Trial Site 13	Kagoshima
Japan	NPO-13 Trial Site 11	Kitakyushu	Fukuoka
Japan	NPO-13 Trial Site 10	Kochi
Japan	NPO-13 Trial Site 12	Kurume	Fukuoka
Japan	NPO-13 Trial Site 2	Maebashi	Gunma
Japan	NPO-13 Trial Site 4	Minato	Tokyo
Japan	NPO-13 Trial Site 7	Osaka
Japan	NPO-13 Trial Site 8	Osaka
Japan	NPO-13 Trial Site 1	Shimotsuke	Tochigi
Japan	NPO-13 Trial Site 3	Shinjuku	Tokyo
Japan	NPO-13 Trial Site 5	Yokohama	Kanagawa
Japan	NPO-13 Trial Site 6	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Time to effect	The onset of anti-spasmodic effect is the interval from the spray to the disappearance of the spasm.	3 minutes
Secondary	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
Secondary	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