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
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.
Study identification
- NCT ID
- NCT01127438
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Interventions
- fospropofol disodium Subgroup 1 Lower Dose Drug
- fospropofol disodium Subgroup 1 Approved Dose Drug
- fospropofol disodium Subgroup 2 Lower Dose Drug
- fospropofol disodium Subgroup 2 Approved Dose Drug
- fospropofol disodium Subgroup 3 Lower Dose Drug
- fospropofol disodium Subgroup 3 Approved 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
- Apr 2010 (Type not available)
- Primary completion
- Jun 2011 (Actual)
- Completion
- Jun 2011 (Actual)
- Last update posted
- Feb 8, 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 8, 2013 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01127438 live on ClinicalTrials.gov.