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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 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nihon Pharmaceutical Co., Ltd

Tracking Information
First Submitted Date  ICMJE August 20, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE August 26, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of NPO-13 During Colonoscopy
Official Title  ICMJE Phase II Study of NPO-13 in Patients Undergoing Colonoscopy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Bowel Disease
Intervention  ICMJE Drug: NPO-13: l-menthol
20 mL/site
Study Arms  ICMJE
  • Active Comparator: NPO-13 0.8%
    Low dose
    Intervention: Drug: NPO-13: l-menthol
  • Active Comparator: NPO-13 1.6%
    High dose
    Intervention: Drug: NPO-13: l-menthol
  • Placebo Comparator: NPO-13 0%
    Placebo
    Intervention: Drug: NPO-13: l-menthol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hisatsugu Asada +81-3-5148-7570 kaihatsu@nihon-pharm.co.jp
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097574
Other Study ID Numbers  ICMJE NPO-13-01/ED-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nihon Pharmaceutical Co., Ltd
Study Sponsor  ICMJE Nihon Pharmaceutical Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hisatsugu Asada Nihon Pharmaceutical Co., Ltd
PRS Account Nihon Pharmaceutical Co., Ltd
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP