NCT04097574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

August 26, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

August 20, 2019

Last Update Submit

August 13, 2020

Conditions

Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment

    3 minutes

  • Change in colonic spasm before and after treatment of NPO-13 treatment

    3 minutes

  • Time to effect

    3 minutes

  • Difficulty of endoscopic observation

    3 minutes

  • Adverse events and Adverse drug reactions

    7 ± 3 days

Study Arms (3)

NPO-13 0.8%

ACTIVE COMPARATOR

Low dose

Drug: NPO-13: l-menthol

NPO-13 1.6%

ACTIVE COMPARATOR

High dose

Drug: NPO-13: l-menthol

NPO-13 0%

PLACEBO COMPARATOR

Placebo

Drug: NPO-13: l-menthol

Interventions

NPO-13: l-mentholDRUG

20 mL/site

NPO-13 0%NPO-13 0.8%NPO-13 1.6%

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are between 20 and 85 years at the time of consent
  • Patients who need colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

NPO-13 Trial Site 11

Kitakyushu, Fukuoka, Japan

Location

NPO-13 Trial Site 12

Kurume, Fukuoka, Japan

Location

NPO-13 Trial Site 2

Maebashi, Gunma, Japan

Location

NPO-13 Trial Site 5

Yokohama, Kanagawa, Japan

Location

NPO-13 Trial Site 6

Yokohama, Kanagawa, Japan

Location

NPO-13 Trial Site 1

Shimotsuke, Tochigi, Japan

Location

NPO-13 Trial Site 4

Minato, Tokyo, Japan

Location

NPO-13 Trial Site 3

Shinjuku, Tokyo, Japan

Location

NPO-13 Trial Site 9

Hiroshima, Japan

Location

NPO-13 Trial Site 13

Kagoshima, Japan

Location

NPO-13 Trial Site 10

Kochi, Japan

Location

NPO-13 Trial Site 7

Osaka, Japan

Location

NPO-13 Trial Site 8

Osaka, Japan

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Hisatsugu Asada

    Nihon Pharmaceutical Co., Ltd

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2019

First Posted

September 20, 2019

Study Start

August 26, 2019

Primary Completion

March 26, 2020

Study Completion

March 26, 2020

Last Updated

August 17, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(13)