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Study of NPO-13 During Colonoscopy

Primary Purpose

Bowel Disease

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
NPO-13: l-menthol
Sponsored by
Nihon Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bowel Disease

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NPO-13 Trial Site 11
  • NPO-13 Trial Site 12
  • NPO-13 Trial Site 2
  • NPO-13 Trial Site 5
  • NPO-13 Trial Site 6
  • NPO-13 Trial Site 1
  • NPO-13 Trial Site 4
  • NPO-13 Trial Site 3
  • NPO-13 Trial Site 9
  • NPO-13 Trial Site 13
  • NPO-13 Trial Site 10
  • NPO-13 Trial Site 7
  • NPO-13 Trial Site 8

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

NPO-13 0.8%

NPO-13 1.6%

NPO-13 0%

Arm Description

Low dose

High dose

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Time to effect
The onset of anti-spasmodic effect is the interval from the spray to the disappearance of the spasm.
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.
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.

Full Information

First Posted
August 20, 2019
Last Updated
August 13, 2020
Sponsor
Nihon Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04097574
Brief Title
Study of NPO-13 During Colonoscopy
Official Title
Phase II Study of NPO-13 in Patients Undergoing Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nihon Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NPO-13 0.8%
Arm Type
Active Comparator
Arm Description
Low dose
Arm Title
NPO-13 1.6%
Arm Type
Active Comparator
Arm Description
High dose
Arm Title
NPO-13 0%
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
NPO-13: l-menthol
Intervention Description
20 mL/site
Primary Outcome Measure Information:
Title
Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment
Description
The primary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment
Description
The secondary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.
Time Frame
3 minutes
Title
Change in colonic spasm before and after treatment of NPO-13 treatment
Description
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.
Time Frame
3 minutes
Title
Time to effect
Description
The onset of anti-spasmodic effect is the interval from the spray to the disappearance of the spasm.
Time Frame
3 minutes
Title
Difficulty of endoscopic observation
Description
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.
Time Frame
3 minutes
Title
Adverse events and Adverse drug reactions
Description
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.
Time Frame
7 ± 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisatsugu Asada
Organizational Affiliation
Nihon Pharmaceutical Co., Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
NPO-13 Trial Site 11
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
NPO-13 Trial Site 12
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
NPO-13 Trial Site 2
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
NPO-13 Trial Site 5
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
NPO-13 Trial Site 6
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
NPO-13 Trial Site 1
City
Shimotsuke
State/Province
Tochigi
Country
Japan
Facility Name
NPO-13 Trial Site 4
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
NPO-13 Trial Site 3
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
NPO-13 Trial Site 9
City
Hiroshima
Country
Japan
Facility Name
NPO-13 Trial Site 13
City
Kagoshima
Country
Japan
Facility Name
NPO-13 Trial Site 10
City
Kochi
Country
Japan
Facility Name
NPO-13 Trial Site 7
City
Osaka
Country
Japan
Facility Name
NPO-13 Trial Site 8
City
Osaka
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of NPO-13 During Colonoscopy

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