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
介入
依頼者(Sponsor)
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