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大腸内視鏡検査中のNPO-13の研究

基本情報

NCT ID
NCT04097574
ステータス
完了
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
158
治験依頼者名
Nihon Pharmaceutical Co., Ltd

概要

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.

対象疾患

Bowel Disease

介入

NPO-13: l-menthol(DRUG)

依頼者(Sponsor)

Nihon(INDUSTRY)

実施施設 (13)

NPO-13 Trial Site 11

Kitakyushu, Fukuoka, Japan

NPO-13 Trial Site 7

Osaka, Japan

NPO-13 Trial Site 3

Shinjuku, Tokyo, Japan

NPO-13 Trial Site 1

Shimotsuke, Tochigi, Japan

NPO-13 Trial Site 8

Osaka, Japan

NPO-13 Trial Site 9

Hiroshima, Japan

NPO-13 Trial Site 6

Yokohama, Kanagawa, Japan

NPO-13 Trial Site 13

Kagoshima, Japan

NPO-13 Trial Site 4

Minato, Tokyo, Japan

NPO-13 Trial Site 10

Kochi, Japan

NPO-13 Trial Site 5

Yokohama, Kanagawa, Japan

NPO-13 Trial Site 12

Kurume, Fukuoka, Japan

NPO-13 Trial Site 2

Maebashi, Gunma, Japan