Phase II study of NPO-13 during colonoscopy

Phase 2

Completed

• Conditions: Patients who receive colonoscopy

• Registration Number: JPRN-jRCT2080224838
• Lead Sponsor: ihon Pharmaceutical Co., Ltd

Brief Summary

When 20 mL of study drug (placebo, NPO-13 0.8% or 1.6%) was administered into the colonic lumen during lower gastrointestinal endoscopy, there was an increase in efficacy with increasing dose. Overall, the 1.6% group showed the highest efficacy, with significant differences in the primary endpoints compared to the placebo group. No new safety concerns or clinically relevant events were observed, and the drug was well tolerated in all treatment groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-20
• Study Completion: 2019-12-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 158

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 subinvestigator's opinion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>exploratory<br>Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment

Secondary Outcome Measures

Name	Time	Method
efficacy<br>exploratory<br>Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment