ClinicalTrials.gov record
Completed Phase 4 Interventional Results available

A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations

ClinicalTrials.gov ID: NCT01127438

Public ClinicalTrials.gov record NCT01127438. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 11, 2026, 2:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-blind, Randomized, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations

Study identification

NCT ID
NCT01127438
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Eisai Inc.
Industry
Enrollment
153 participants

Conditions and interventions

Conditions

Interventions

  • fospropofol disodium Subgroup 1 Approved Dose Drug
  • fospropofol disodium Subgroup 1 Lower Dose Drug
  • fospropofol disodium Subgroup 2 Approved Dose Drug
  • fospropofol disodium Subgroup 2 Lower Dose Drug
  • fospropofol disodium Subgroup 3 Approved Dose Drug
  • fospropofol disodium Subgroup 3 Lower Dose Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2010
Primary completion
May 31, 2011
Completion
May 31, 2011
Last update posted
Feb 7, 2013

2010 – 2011

United States locations

U.S. sites
23
U.S. states
13
U.S. cities
23
Facility City State ZIP Site status
Hope Research Institute Phoenix Arizona 85050
Southern California Permanente Medical Group Baldwin Park California 91706
Desta Digestive Disease Medical Center San Diego California 92114
Washington Hospital Center Washington D.C. District of Columbia 20010
Center for Advanced Gastroenterology Maitland Florida 32751
University of Miami School of Medicine Miami Florida 33136
Miami Research Associates South Miami Florida 33143
Sheridan Clinical Research Sunrise Florida 33323
Gastrointestinal Specialists of Georgia, PC Marietta Georgia 30060
Creighton University Medical Center Omaha Nebraska 68131
Research Associates of New York, LLP New York New York 10075
Duke University Durham North Carolina 27710
Ohio State University Medical Center Department of Anesthesiology Columbus Ohio 43210
Ilumina Clinical Associates, Keystone Headache and Pain Mgt Center, Tyrone Hospital Tyrone Pennsylvania 16686
Ilumina Clinical Associates Uniontown Pennsylvania 15401
Digestive Health Associates Plano Texas 75075
Clinical Trial Network Spring Texas 77386
Utah Digestive Health Institute Clinton Utah 84015
Northern Utah Gastroenterology Logan Utah 84341-2534
Advance Clinical Research Odgen Utah 84405
Utah Clinical Trials, LLC Salt Lake City Utah 84107
Charlottesville Medical Research Charlottesville Virginia 22911
Gastroenterology Associates of Northern Virginia Fairfax Virginia 22031

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01127438, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 7, 2013 · Synced May 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01127438 live on ClinicalTrials.gov.

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