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| Sponsored by: |
MGI PHARMA, Inc. |
| Information provided by: | MGI PHARMA, Inc. |
| ClinicalTrials.gov Identifier: | NCT00327392 |
Purpose
Very often patients receive medications 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. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.
| Condition | Intervention | Phase |
|
Procedural Sedation |
Drug: AQUAVAN® (fospropofol disodium) Injection |
Phase II Phase III |
| ChemIDplus related topics: | GPI 15715 |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase 3 Open-Label, Single Arm Study to Assess the Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal-to-Moderate Sedation in Patients Undergoing Minor Surgical Procedures |
| Estimated Enrollment: | 125 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2007 |
This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Number of sites/patients: Approximately 18 sites and 125 patients.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |||||
| Precision Trials | |||||
| Phoenix, Arizona, United States, 85032 | |||||
| United States, Florida | |||||
| Borland-Groover Clinic | |||||
| Jacksonville, Florida, United States, 32256 | |||||
| United States, Kentucky | |||||
| University of Louisville | |||||
| Louisville, Kentucky, United States, 40202 | |||||
| United States, Louisiana | |||||
| Medical Research Institute, Inc. | |||||
| Slidell, Louisiana, United States, 70458 | |||||
| Medical Research Institute | |||||
| Slidell, Louisiana, United States, 70458 | |||||
| United States, Maryland | |||||
| Chesapeake Research Group, LLC | |||||
| Pasadena, Maryland, United States, 21122 | |||||
| Chevy Chase Clinical Research | |||||
| Chevy Chase, Maryland, United States, 20815 | |||||
| United States, Missouri | |||||
| St. Louis Women's Healthcare Group | |||||
| Chesterfield, Missouri, United States, 63017 | |||||
| United States, Montana | |||||
| International Heart Institute of Montana | |||||
| Missoula, Montana, United States, 59802 | |||||
| United States, New York | |||||
| Hudson Valley Urology, PC | |||||
| Poughkeepsie, New York, United States, 12601 | |||||
| United States, North Carolina | |||||
| Duke University Medical Center | |||||
| Durham, North Carolina, United States, 27710 | |||||
| United States, South Carolina | |||||
| Carolina Urologic Research | |||||
| Myrtle Beach, South Carolina, United States, 29572 | |||||
| Southern Orthopaedic Sports Medicine | |||||
| Columbia, South Carolina, United States, 29204 | |||||
| United States, Texas | |||||
| Dallas VA Medical Center | |||||
| Dallas, Texas, United States, 75216 | |||||
| United States, Utah | |||||
| Physicians' Research Options | |||||
| Sandy, Utah, United States, 84070 | |||||
| MGI PHARMA, Inc. |
| Study Director: | James B Jones, MD, PharmD | MGI PHARMA, Inc. |
More Information
| Study ID Numbers: | 3000-0523 |
| First Received: | May 16, 2006 |
| Last Updated: | December 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00327392 |
| Health Authority: | United States: Food and Drug Administration |
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