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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy

Intervention / Treatment
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* Drug: Intralipid
* Drug: ICI35,868 (Diprivan)
* Drug: ICI35,868 (Diprivan) + EES0000645/A (SDS)


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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>Group 1 (placebo group) is treated by Anaesthesiologist | Drug: Intralipid<br>* Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.)<br>|
| Active Comparator: Group 2<br>Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist | Drug: ICI35,868 (Diprivan)<br>* Treated by Anaesthesiologist<br>|
| Active Comparator: Group 3<br>Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist | Drug: ICI35,868 (Diprivan) + EES0000645/A (SDS)<br>* Treated by Endoscopist with EES0000645/A(SDS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achivement of Target Sedation | 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. | from scope-in to scope-out | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSSI Total Score | 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) | at 24-48 h after endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, propofol, gastrointestinal endoscopy