GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting
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|ClinicalTrials.gov Identifier: NCT00125398|
Recruitment Status : Completed
First Posted : August 1, 2005
Last Update Posted : November 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Sedation Intubation Respiration, Artificial||Drug: AQUAVAN (fospropofol disodium; GPI 15715 )||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2005|
|Actual Study Completion Date :||May 2007|
- Safety and tolerability of infusions
- Percentage of patients requiring rescue medications
- Evaluation of the onset of effect
- Evaluation of satisfaction with sedation
- Determination of pharmacokinetic (PK) levels of GPI 15715 in blood
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125398
|Study Director:||James Jones, MD, PharmD||Eisai Inc.|