NCT01189604

Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests

A Multi-centre, Single-blind, Randomised, Parallel Group, Phase IIb Dose Rate Range Finding Study to Find Maintenance Dose Rate Range of ICI35,868 for the Minimal-to-moderate Sedation on Gastrointestinal Endoscopic Tests (Including Endoscopic Polypectomy)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.

Conditions

• Gastrointestinal Endoscopy
• Gastrointestinal Polypectomy

Interventions

Type	Name	Description
DRUG	Placebo	Infusion of placebo, same infusion rates as for arm 2
DRUG	ICI35,868 (propofol)	Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
DRUG	ICI35,868 (propofol)	Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
DRUG	ICI35,868 (propofol)	Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
DRUG	ICI35,868 (propofol)	Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
DRUG	ICI35,868 (propofol)	Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
DRUG	ICI35,868 (propofol)	Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-08-26
• Last updated: 2011-12-19
• Results posted: 2011-12-13

Locations

2 sites across 1 country: Japan