ICI35,868（ディプリバン）とEES0000645/A（SDS）の併用および非併用による消化管内視鏡検査に関する第III相試験

基本情報

NCT ID: NCT01961349
ステータス: 完了
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 279
治験依頼者名: AstraZeneca

概要

This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled, phase III confirmatory study. The study will be partially double-blinded: the comparison between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried out in double-blind, but the comparison between Group 1 (placebo group) and Group 3 (ICI35,868 with EES0000645/A) will be carried out in single-blind. The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy will be evaluated.

対象疾患

Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy

介入

Intralipid(DRUG)

ICI35,868 (Diprivan)(DRUG)

ICI35,868 (Diprivan) + EES0000645/A (SDS)(DRUG)

依頼者（Sponsor）

アストラゼネカ株式会社(INDUSTRY)

ヤンセンファーマ株式会社(INDUSTRY)