Skip to main content
OpenTrials
Completed

NCT Number: NCT01961349

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Moriya-shi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intralipid

Drug

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)

Primary outcomes

  1. Achivement of Target Sedation

    Time frame: 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 outcomes

  1. PSSI Total Score

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Johnson & Johnson

Registry information

Official study 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

Acronym: Kagami_SDS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 11, 2013
Registry last updated
Nov 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.