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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
158
20 mL/site
NPO-13 Trial Site 11
Kitakyushu, Fukuoka, Japan
NPO-13 Trial Site 12
Kurume, Fukuoka, Japan
NPO-13 Trial Site 2
Maebashi, Gunma, Japan
Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment
The primary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.
Time frame: 3 minutes
Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment
The secondary endpoint will be evaluated by third-party organization, using a four-grade scale: 1, No; 2, Mild; 3, Moderate; 4, Severe.
Time frame: 3 minutes
Change in colonic spasm before and after treatment of NPO-13 treatment
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 frame: 3 minutes
Time to effect
The onset of anti-spasmodic effect is the interval from the spray to the disappearance of the spasm.
Time frame: 3 minutes
Difficulty of endoscopic observation
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.
Time frame: 3 minutes
Adverse events and Adverse drug reactions
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.
Time frame: 7 ± 3 days
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NPO-13 Trial Site 5
Yokohama, Kanagawa, Japan
NPO-13 Trial Site 6
Yokohama, Kanagawa, Japan
NPO-13 Trial Site 1
Shimotsuke, Tochigi, Japan
NPO-13 Trial Site 4
Minato, Tokyo, Japan
NPO-13 Trial Site 3
Shinjuku, Tokyo, Japan
NPO-13 Trial Site 9
Hiroshima, Japan
NPO-13 Trial Site 13
Kagoshima, Japan
...and 3 more locations