Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy

Phase 3

Completed

• Conditions: Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
• Interventions: Drug: ICI35,868 (Diprivan); Drug: ICI35,868 (Diprivan) + EES0000645/A (SDS); Drug: Intralipid

• Registration Number: NCT01961349
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2015-03-24
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-27
• Last Update Submitted: 2015-10-27
• Results First Posted: 2015-11-27
• Last Update Posted: 2015-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

1.Provision of written informed consent prior to any study-related procedures/examinations 2.Aged 20 years and older 3.Subjects who are planned to undergo a non-emergent EGD or colonoscopy, including gastrointestinal endoscopic polypectomy that shall be completed within 1 hour (excluding the endoscopic submucosal dissection and ultrasonic endoscope, pernasal endoscope, etc.).

Exclusion Criteria

1. involvement in the planning and/or conduct of the study (applies to both sponsor's employees and/or staffs at the study site)
2. Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year.
3. Participation in another clinical study with an investigational product within 4 weeks prior to randomisation.
4. Baseline (Visit 1) of blood oxygen saturation (SpO2)<90% (room air)
5. ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory, renal, liver, pancreatic or endocrine function.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	ICI35,868 (Diprivan)	Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist
Group 3	ICI35,868 (Diprivan) + EES0000645/A (SDS)	Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist
Group 1	Intralipid	Group 1 (placebo group) is treated by Anaesthesiologist

Primary Outcome Measures

Name	Time	Method
Achivement of Target Sedation	from scope-in to scope-out	The target sedation is defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores 2 to 4 for ≥50% of all MOAA/S measurements from scope-in to scope-out.

Secondary Outcome Measures

Name	Time	Method
PSSI Total Score	at 24-48 h after endoscopy	PSSI (Statistics of Patient Satisfaction with Sedation Instrument) total score obtained from 20 questions (1 to 7 points for each) adjusted to have range of 0 ( very dissatisfied: all items scored with 1 point) to 100 (very satisfied: all items scored with 7 points)

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yokohama-shi, Japan