Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy Clinical Trial
Official title:
A Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III Confirmatory Study to Assess Efficacy and Safety of the Moderate Sedation of ICI35,868 With and Without EES0000645/A on Gastrointestinal Endoscopy
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment