Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
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.