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Phase II exploratory study of NPO-13 in patients undergoing colonoscopy

Phase II study of NPO-13 during colonoscopy

158

Of the 228 patients enrolled, 158 received the study drug. No subjects were excluded from the FAS due to serious GCP deviation. Males and females accounted for 76.6% and 23.4% of all subjects respectively. The mean(SD) of age was 58.0 (15.07), and the meanof BMI was 23.37(3.506) kg/m2. The classification of intestinal contraction before administration of the study drug was 4 degrees in 54.6% of all administered sites. The presence of contraction movements that interfered with observation before administration of the investigational drug was "yes" in 83.3% of all administered sites.

The incidence of adverse events was 3.8% (2/52) in the placebo group, 1.9% (1/53) in the 0.8% group, and 5.7% (3/53) in the 1.6% group. There were no significant differences between the 0.8% and 1.6% groups compared to the placebo group at the 5% level of significance on both sides. The incidence of adverse drug reactions by treatment group was 0% (0/52) in the placebo group, 1.9% (1/53) in the 0.8% group, and 0% (0/53) in the 1.6% group. There were no significant differences between the 0.8% and 1.6% groups compared to the placebo group at the 5% level of significance on both sides. No deaths occurred, and other serious adverse events occurred in 1.9% (1/53) of patients in the 1.6% group. No adverse events resulted in discontinuation or dose reduction of study drug.

The percentage of effective sites (number of effective sites/evaluated sites, 95% confidence interval) in the PPS among all sites (ascending and sigmoid colon) was 32.4% (22/68 sites, 21.5-44.8) in the placebo group, 41.8% (28/67 sites, 29.8-54.5) in the 0.8% group, and 53.6% (37/69 sites, 41.2-65.7). When compared using Fisher's direct probability test, there was a statistically significant difference between the 1.6% group and the placebo group at the 5% two-sided level of significance (p = 0.015); there was no statistically significant difference between the 0.8% group and the placebo group (p = 0.287).

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.

No

Nihon Pharmaceutical Co., Ltd

8-1, Akashi-cho, Chuo-ku, Tokyo, JAPAN

kaihatsu@nihon-pharm.co.jp

Nihon Pharmaceutical Co., Ltd

8-1, Akashi-cho, Chuo-ku, Tokyo, JAPAN

+81-3-5148-7574

kaihatsu@nihon-pharm.co.jp

completed

Aug. 26, 2019

Interventional

Placebo Control, Randomized, Double-Blind, Multi-center, Parallel Assignment Study

diagnostic purpose

2

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

(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

Both

Patients who receive colonoscopy

investigational material(s)
Generic name etc : l-menthol
INN of investigational material : levo menthol
Therapeutic category code : 799 Agents for not mainly purpose of therapeutic, n.e.c.
Dosage and Administration for Investigational material : 20mL /site

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

efficacy
exploratory
Proportion of No or Mild colonic spasm at the all sites of NPO-13 treatment

efficacy
exploratory
Proportion of No or Mild colonic spasm at the each site of NPO-13 treatment

Aug. 29, 2019