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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01961349
D0092C00002

Details and patient eligibility

About

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.

Enrollment

279 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

279 participants in 3 patient groups, including a placebo group

Group 1
Placebo Comparator group
Description:
Group 1 (placebo group) is treated by Anaesthesiologist
Treatment:
Drug: Intralipid
Group 2
Active Comparator group
Description:
Group 2 (ICI35,868 without EES0000645/A) is treated by Anaesthesiologist
Treatment:
Drug: ICI35,868 (Diprivan)
Group 3
Active Comparator group
Description:
Group 3 (ICI35,868 with EES0000645/A) is treated by Endoscopist
Treatment:
Drug: ICI35,868 (Diprivan) + EES0000645/A (SDS)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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