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Phase Ⅱ Dose Response Study of NPO-13 in Patients Undergoing Total Colonoscopy

Primary Purpose

Bowel Disease

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
NPO-13
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected colonic disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.

  1. Patients who need colonoscopy
  2. Patients who are older than 20 years at the time of consent

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. Patients on cancer treatment (chemotherapy or radiotherapy)
  6. Patients who need sedative colonoscopy
  7. Patients who receives a therapeutic colonoscopy
  8. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
  9. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
  10. Patients who have been exposed to NPO-13
  11. Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

0% NPO-13

0.2% NPO-13

0.4% NPO-13

0.8% NPO-13

Arm Description

Placebo

Low dose

Medium dose

High dose

Outcomes

Primary Outcome Measures

The proportion of the splayed region with no contraction after NPO-13 dosage

Secondary Outcome Measures

The proportion of the splayed region with an onset of action
The proportion of patients with no contraction in all the sprayed regions
The proportion of patients with no contraction in one or more the sprayed region
Change in colonic contraction
Adverse events and ADRs observed between administration and 7 ± 3 days after administration

Full Information

First Posted
October 11, 2014
Last Updated
November 15, 2021
Sponsor
Nihon Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02265939
Brief Title
Phase Ⅱ Dose Response Study of NPO-13 in Patients Undergoing Total Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13 per contraction region of large bowel up to fifth times during the colonoscopy. The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be assessed by an independent committee using recorded video images. The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.

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
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0% NPO-13
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
0.2% NPO-13
Arm Type
Active Comparator
Arm Description
Low dose
Arm Title
0.4% NPO-13
Arm Type
Active Comparator
Arm Description
Medium dose
Arm Title
0.8% NPO-13
Arm Type
Active Comparator
Arm Description
High dose
Intervention Type
Drug
Intervention Name(s)
NPO-13
Primary Outcome Measure Information:
Title
The proportion of the splayed region with no contraction after NPO-13 dosage
Time Frame
3 min
Secondary Outcome Measure Information:
Title
The proportion of the splayed region with an onset of action
Time Frame
3 min
Title
The proportion of patients with no contraction in all the sprayed regions
Time Frame
3 min
Title
The proportion of patients with no contraction in one or more the sprayed region
Time Frame
3 min
Title
Change in colonic contraction
Time Frame
3 min
Title
Adverse events and ADRs observed between administration and 7 ± 3 days after administration
Time Frame
up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected colonic disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study. Patients who need colonoscopy Patients who are older than 20 years at the time of consent 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 Patients on cancer treatment (chemotherapy or radiotherapy) Patients who need sedative 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 who have been exposed to NPO-13 Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Facility Information:
City
Fukuoka
Country
Japan
City
Osaka
Country
Japan
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Phase Ⅱ Dose Response Study of NPO-13 in Patients Undergoing Total Colonoscopy

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