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A Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Confirmatory Study to Assess Efficacy and Safety of the Moderate Sedation of ICI35,868 With and Without EES0000645/A on Gastrointestinal Endoscopy

A Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Confirmatory Study to Assess Efficacy and Safety of the Moderate Sedation of ICI35,868 With and Without EES0000645/A on Gastrointestinal Endoscopy

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222312
Enrollment
Unknown
Registered
2013-11-26
Start date
2013-11-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects who undergo gastrointestinal diagnostic endoscopy or gastrointestinal endoscopic polypectomy

Interventions

investigational material(s) Generic name etc : Propofol(ICI35,868) INN of investigational material : Propofol Therapeutic category code : 111 General anesthetics Dosage and Administration for Investig

Sponsors

AstraZeneca
Lead Sponsor
Johnson & Johnson
Collaborator

Eligibility

Sex/Gender
All

Inclusion 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

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.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026