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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Johnson & Johnson
• Treatments: Propofol; Soybean oil, phospholipid emulsion

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.