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

NCT02265939 | Completed Phase 2

• 1 other identifier: NPO-13
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

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.

Conditions

Bowel Disease

Outcome Measures

Primary Outcomes (1)

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

  3 min

Secondary Outcomes (5)

• 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

Study Arms (4)

0% NPO-13

PLACEBO COMPARATOR

Placebo

Drug: NPO-13

0.2% NPO-13

ACTIVE COMPARATOR

Low dose

Drug: NPO-13

0.4% NPO-13

ACTIVE COMPARATOR

Medium dose

Drug: NPO-13

0.8% NPO-13

ACTIVE COMPARATOR

High dose

Drug: NPO-13

Interventions

NPO-13 DRUG

0% NPO-13; 0.2% NPO-13; 0.4% NPO-13; 0.8% NPO-13

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Nihon Pharmaceutical Co., Ltd: lead

Study Sites (3)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

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: October 11, 2014
• First Posted: October 16, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 16, 2021

Record last verified: 2015-04

Locations

JP (3)