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

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

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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)