Dose rate range finding study of propofol for minimal-to moderate sedation on upper & lower endoscopic tests

Study identifier:D0092C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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)

Medical condition

gastrointestinal endoscopy

Phase

Phase 2

Healthy volunteers

No

Study drug

Placebo, ICI35,868 (propofol)

Sex

All

Actual Enrollment

123

Study type

Interventional

Age

20 Years +

Date

Study Start Date: 01 Aug 2010
Primary Completion Date: 01 Nov 2010
Study Completion Date: 01 Nov 2010

Study design

Allocation: Randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2011 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Johnson & Johnson K.K. Medical Company

Inclusion and exclusion criteria