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

NCT01189604 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2011-12-19

Study results available
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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

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

Sponsors & Collaborators

  • Johnson & Johnson K.K. Medical Company

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Masataka Date, M.D., Ph.D. · Physician Group, Clinical Division, R&D, Astrazeneca K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01189604 on ClinicalTrials.gov