Study of NPO-13 During Colonoscopy

Phase II Study of NPO-13 in Patients Undergoing Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: Bowel Disease
• Intervention / Treatment: Drug: NPO-13: l-menthol

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nihon Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2019
• Primary Completion (Actual): March 26, 2020
• Study Completion (Actual): March 26, 2020

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: NPO-13-01/ED-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No