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Completed

NCT Number: NCT04097574

Study of NPO-13 During Colonoscopy

This study will investigate the safety, efficacy and dose-response of NPO-13 in subjects with moderate to severe colonic spasm during colonoscopy. An intraluminal spraying of NPO-13 dosed up to twice into ascending or sigmoid colon. The colonic spasm will be assessed by an independent committee using recorded video images. The study consists of a screening visit window, 1-day treatment phase and 1-week follow-up phase.

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Key information

Conditions

Bowel Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NPO-13 Trial Site 11, Kitakyushu, 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

  • Patients who are between 20 and 85 years at the time of consent
  • Patients who need colonoscopy

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
  • Patient with contraindication to pain medicine and sedative medicine
  • Patient with contraindication to butylscopolamine bromide and glucagon
  • Patients on cancer treatment (chemotherapy or radiotherapy)
  • Patient with active inflammatory bowel disease or infectious enteritis
  • Patients who need sedative in 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 otherwise ineligible for participation in the study in the investigator's or coinvestigator's opinion

Treatment and study plan

NPO-13: l-menthol

Drug

20 mL/site

Primary outcomes

  1. Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment

    Time frame: 3 minutes

    The primary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.

Secondary outcomes

  1. Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment

    Time frame: 3 minutes

    The secondary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.

  2. Change in colonic spasm before and after treatment of NPO-13 treatment

    Time frame: 3 minutes

    The evaluated colonic spasm grades will be converted into a numeric score, and difference between paired mean scores (before and after application, or 0.8% NPO-13, 1.6% NPO-13 and placebo) will be calculated.

  3. Time to effect

    Time frame: 3 minutes

    The onset of anti-spasmodic effect is the interval from the spray to the disappearance of the spasm.

  4. Difficulty of endoscopic observation

    Time frame: 3 minutes

    The proportion of subjects in whom intracolonic examination will be evaluated by the investigator to be "Very easy" or "Easy"., using a four-grade scale: 1, Very easy; 2, Easy; 3, Difficult; 4, Hard.

  5. Adverse events and Adverse drug reactions

    Time frame: 7 ± 3 days

    The subjects will be observed for 7 days after colonoscopy, and all adverse events and adverse drug reactions will be recorded and compared with the placebo group.

Sponsors and collaborators

Lead sponsor

Nihon Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

Phase II Study of NPO-13 in Patients Undergoing Colonoscopy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 20, 2019
Registry last updated
Aug 17, 2020

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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