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Completed

NCT Number: NCT02265939

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.

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Key information

Conditions

Bowel Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NPO-13

Drug

Primary outcomes

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

    Time frame: 3 min

Secondary outcomes

  1. The proportion of the splayed region with an onset of action

    Time frame: 3 min

  2. The proportion of patients with no contraction in all the sprayed regions

    Time frame: 3 min

  3. The proportion of patients with no contraction in one or more the sprayed region

    Time frame: 3 min

  4. Change in colonic contraction

    Time frame: 3 min

  5. Adverse events and ADRs observed between administration and 7 ± 3 days after administration

    Time frame: up to 10 days

Sponsors and collaborators

Lead sponsor

Nihon Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2014
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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