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Study of AQUAVAN® Injection (AQUAVAN; Fospropofol Disodium) for Sedation During Colonoscopy

NCT00125424 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2008-11-07

No results posted yet for this study

Summary

Very often, patients receive sedative medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. During procedural (mild to moderate) sedation, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is made as a slow release version of propofol, allowing for fast sedation and possibly faster recovery and discharge.

This study is intended to compare several different doses of AQUAVAN in patients having a colonoscopy in order to find the right dose that will get patients to a level of mild to moderate (procedural) sedation.

Conditions

  • Colonoscopy
  • Colonic Polyps

Interventions

DRUG

AQUAVAN® (fospropofol disodium) Injection

DRUG

Midazolam HCl

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • James Jones, PharmD, MD · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Completion
2005-09-30

Countries

  • United States

Study Locations

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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 NCT00125424 on ClinicalTrials.gov