Phase III study of ICI35,868 (Diprivan) with and without EES0000645/A (SDS) on gastrointestinal endoscopy - Kagami_SDS

Study identifier:D0092C00002

ClinicalTrials.gov identifier:NCT01961349

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy

Phase

Phase 3

Healthy volunteers

No

Study drug

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

Sex

All

Actual Enrollment

279

Study type

Interventional

Age

20 Years +

Date

Study Start Date: 01 Oct 2013
Primary Completion Date: 01 Mar 2014
Study Completion Date: 01 Mar 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2015 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Johnson & Johnson

Inclusion and exclusion criteria