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Study of NPO-13 During Colonoscopy

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ClinicalTrials.gov Identifier: NCT04097574
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bowel Disease Drug: NPO-13: l-menthol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Phase II Study of NPO-13 in Patients Undergoing Colonoscopy
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Menthol

Arm Intervention/treatment
Active Comparator: NPO-13 0.8%
Low dose
Drug: NPO-13: l-menthol
20 mL/site

Active Comparator: NPO-13 1.6%
High dose
Drug: NPO-13: l-menthol
20 mL/site

Placebo Comparator: NPO-13 0%
Placebo
Drug: NPO-13: l-menthol
20 mL/site




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who are between 20 and 85 years at the time of consent
  2. Patients who need colonoscopy

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. Patient with contraindication to pain medicine and sedative medicine
  6. Patient with contraindication to butylscopolamine bromide and glucagon
  7. Patients on cancer treatment (chemotherapy or radiotherapy)
  8. Patient with active inflammatory bowel disease or infectious enteritis
  9. Patients who need sedative in colonoscopy
  10. Patients who receives a therapeutic colonoscopy
  11. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
  12. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
  13. Patients otherwise ineligible for participation in the study in the investigator's or coinvestigator's opinion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097574


Contacts
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Contact: Hisatsugu Asada +81-3-5148-7570 kaihatsu@nihon-pharm.co.jp

Locations
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Japan
NPO-13 Trial Site 11 Recruiting
Kitakyushu, Fukuoka, Japan
NPO-13 Trial Site 12 Not yet recruiting
Kurume, Fukuoka, Japan
NPO-13 Trial Site 2 Not yet recruiting
Maebashi, Gunma, Japan
NPO-13 Trial Site 5 Recruiting
Yokohama, Kanagawa, Japan
NPO-13 Trial Site 6 Not yet recruiting
Yokohama, Kanagawa, Japan
NPO-13 Trial Site 1 Not yet recruiting
Shimotsuke, Tochigi, Japan
NPO-13 Trial Site 4 Not yet recruiting
Minato, Tokyo, Japan
NPO-13 Trial Site 3 Not yet recruiting
Shinjuku, Tokyo, Japan
NPO-13 Trial Site 9 Not yet recruiting
Hiroshima, Japan
NPO-13 Trial Site 13 Not yet recruiting
Kagoshima, Japan
NPO-13 Trial Site 10 Recruiting
Kochi, Japan
NPO-13 Trial Site 7 Not yet recruiting
Osaka, Japan
NPO-13 Trial Site 8 Recruiting
Osaka, Japan
Sponsors and Collaborators
Nihon Pharmaceutical Co., Ltd
Investigators
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Study Chair: Hisatsugu Asada Nihon Pharmaceutical Co., Ltd

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Responsible Party: Nihon Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT04097574     History of Changes
Other Study ID Numbers: NPO-13-01/ED-01
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Menthol
Antipruritics
Dermatologic Agents