CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 279 enrolled
Drug / intervention
Intralipid +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01961349
NCT01961349Phase 3Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Oct 11, 2013·Updated Nov 27, 2015

In Brief

A Phase 3 clinical trial evaluating Intralipid, ICI35,868 (Diprivan), and 1 other intervention for Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy. Completed, enrolled 279 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
CountriesJapan
CollaboratorsJohnson & Johnson

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 11, 2013
Enrollment StartOct 1, 2013
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.7 years ago

Interventions

Intralipiddrug

Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.)

ICI35,868 (Diprivan)drug

Treated by Anaesthesiologist

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

Treated by Endoscopist with EES0000645/A(SDS)