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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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NPO-13

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

0% NPO-13

NPO-13

0.2% NPO-13

NPO-13

0.4% NPO-13

NPO-13

0.8% NPO-13

NPO-13

Interventions

NPO-13

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Nihon Pharmaceutical Co., Ltd

Responsible Party

Locations

Countries

Other Identifiers

NPO-13