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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
  • Osaka, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0% NPO-13; Placebo	Drug: NPO-13
Active Comparator: 0.2% NPO-13; Low dose	Drug: NPO-13
Active Comparator: 0.4% NPO-13; Medium dose	Drug: NPO-13
Active Comparator: 0.8% NPO-13; High dose	Drug: NPO-13

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of the splayed region with no contraction after NPO-13 dosage	3 min

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of the splayed region with an onset of action	3 min
The proportion of patients with no contraction in all the sprayed regions	3 min
The proportion of patients with no contraction in one or more the sprayed region	3 min
Change in colonic contraction	3 min
Adverse events and ADRs observed between administration and 7 ± 3 days after administration	up to 10 days

Collaborators and Investigators

• Sponsor: Nihon Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 11, 2014
• First Submitted That Met QC Criteria: October 11, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: NPO-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No