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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00125398 |
Patients who are in the intensive care unit after surgery and require mechanical breathing support (intubation and ventilation) usually require sedation to avoid agitation and excessive stress responses. Short-acting sedatives such as midazolam and propofol are the drugs typically used for this. Propofol provides for fast sedation and fast recovery from sedation. Midazolam is slower to sedation and slower for recovery, but may provide some advantages over propofol, such as a lower incidence of hypotension (low blood pressure). This study will look at propofol compared to a product with fast sedation and recovery like that of propofol but with less of a chance for hypotension like with midazolam. Patients will be treated with the product for up to 8 hours and then will be monitored for 8 hours following treatment.
Condition | Intervention | Phase |
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Postoperative Sedation Intubation Respiration, Artificial |
Drug: AQUAVAN (fospropofol disodium; GPI 15715 ) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Open-Label Study to Examine the Safety and Efficacy of GPI 15715 for Sedation of Patients Requiring Intubation and Mechanical Ventilation in the Intensive Care Unit Setting |
Estimated Enrollment: | 60 |
Study Start Date: | July 2005 |
Study Completion Date: | May 2007 |
Patients who are intubated and ventilated and will require up to 8 hours of sedation in the ICU are eligible for participation in this study. Patients will be randomized to receive 1 of 3 treatments. One treatment is standard of care, a propofol infusion. The other two treatment arms are infusions of GPI 15715 (AQUAVAN), one with a bolus and one without.
Patients will be treated for up to 8 hours and monitored for eight hours post treatment. If there are signs of agitation during the up to 8 hour treatment period, the infusion of the sedative medicine will be increased according to protocol.
Blood samples will be obtained periodically during the course of the study for safety evaluation and pharmacokinetic assessments. When the patient is ready for extubation or the end of the 8 hour study period has been reached, the infusion of the sedative agent will be discontinued and the patient will be monitored for 8 hours post treatment.
Guilford Pharmaceuticals was acquired by MGI PHARMA on October 3, 2005.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
St. Mary's Hospital | |
Rogers, Arizona, United States, 72756 | |
United States, Florida | |
Jackson Memorial Hospital | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
Advocate Lutheran General Hospital | |
Park Ridge, Illinois, United States, 60068 | |
United States, Iowa | |
University of Iowa Hospital and Clinics | |
Iowa City, Iowa, United States, 52242 | |
United States, Maine | |
Central Maine Pulmonary Associates | |
Auburn, Maine, United States, 04210 | |
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 | |
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
New York University School of Medicine | |
New York, New York, United States, 10016 | |
Long Island Jewish Medical Center | |
New Hyde Park, New York, United States, 11040 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
Wake Forest University Baptist Medical Center | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Oklahoma | |
Oklahoma University Medical Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Department of Veterans Affairs, North Texas Health Care System | |
Dallas, Texas, United States, 75216 |
Study Director: | James Jones, MD, PharmD | Eisai Medical Research Inc. |
Study ID Numbers: | 3000-0413, GPI 3000-0413, Sedation in an ICU Setting |
Study First Received: | July 28, 2005 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00125398 |
Health Authority: | United States: Food and Drug Administration |
AQUAVAN GPI 15715 ICU Sedation |