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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Group 1 Group 1 (placebo group) is treated by Anaesthesiologist | Drug: Intralipid Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.) |
| Active Comparator: Group 2 Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist | Drug: ICI35,868 (Diprivan) Treated by Anaesthesiologist |
| Active Comparator: Group 3 Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist | Drug: ICI35,868 (Diprivan) + EES0000645/A (SDS) Treated by Endoscopist with EES0000645/A(SDS) |
