全大腸内視鏡検査を受ける患者におけるNPO-13の第Ⅱ相用量反応試験

基本情報

NCT ID

NCT02265939

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

132

治験依頼者名

Nihon Pharmaceutical Co., Ltd

概要

Patients who require screening colonoscopy will receive an intraluminal spraying of NPO-13 per contraction region of large bowel up to fifth times during the colonoscopy. The efficacy of NPO-13 will be evaluated based on the proportion of the splayed region with no contraction after NPO-13 dosage (primary outcome measure). The colonic spasm will be assessed by an independent committee using recorded video images. The safety of NPO-13 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.

対象疾患

介入

依頼者（Sponsor）