Clinical trial NCT04097574: Study of NPO-13 During Colonoscopy
Official title: Phase II Study of NPO-13 in Patients Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bowel Disease
Lead sponsor: Nihon Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-09-20
Enrollment: 158
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment
timeFrame: 3 minutes
Secondary outcomes:
measure: Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment
timeFrame: 3 minutes
measure: Change in colonic spasm before and after treatment of NPO-13 treatment
timeFrame: 3 minutes
measure: Time to effect
timeFrame: 3 minutes
measure: Difficulty of endoscopic observation
timeFrame: 3 minutes
measure: Adverse events and Adverse drug reactions
timeFrame: 7 ± 3 days
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: NPO-13 Trial Site 11
state: Fukuoka
city: Kurume
country: Japan
facility: NPO-13 Trial Site 12
state: Fukuoka
city: Maebashi
country: Japan
facility: NPO-13 Trial Site 2
state: Gunma
city: Yokohama
country: Japan
facility: NPO-13 Trial Site 5
state: Kanagawa
city: Yokohama
country: Japan
facility: NPO-13 Trial Site 6
state: Kanagawa
city: Shimotsuke
country: Japan
facility: NPO-13 Trial Site 1
state: Tochigi
city: Minato
country: Japan
facility: NPO-13 Trial Site 4
state: Tokyo
city: Shinjuku
country: Japan
facility: NPO-13 Trial Site 3
state: Tokyo
city: Hiroshima
country: Japan
facility: NPO-13 Trial Site 9
city: Kagoshima
country: Japan
facility: NPO-13 Trial Site 13
city: Kochi
country: Japan
facility: NPO-13 Trial Site 10
city: Osaka
country: Japan
facility: NPO-13 Trial Site 7
city: Osaka
country: Japan
facility: NPO-13 Trial Site 8
Study officials:
affiliation: Nihon Pharmaceutical Co., Ltd
name: Hisatsugu Asada
role: STUDY_CHAIR
References: