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A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy

NCT00209573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2008-11-07

No results posted yet for this study

Summary

This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in patients undergoing colonoscopy as well as to assess the safety profile of AQUAVAN versus that of midazolam. Prior to the procedure, patients received fentanyl citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.

Conditions

  • Colonoscopy
  • Colon Polyps

Interventions

DRUG

fospropofol disodium

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Bio Analytical Research Corporation

    collaborator INDUSTRY

  • MDS Pharma Services

    collaborator INDUSTRY

  • Coghlan Group (Plasma Sample Supplies)

    collaborator UNKNOWN

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • James Jones, MD,PharmD · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2004-12-31

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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 NCT00209573 on ClinicalTrials.gov