GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting
Public ClinicalTrials.gov record NCT00125398. 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 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00125398
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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
- Jun 30, 2005
- Primary completion
- Not listed
- Completion
- Apr 30, 2007
- Last update posted
- Nov 6, 2008
2005 – 2007
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Mary's Hospital | Rogers | Arizona | 72756 | — |
| Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | — |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | — |
| Central Maine Pulmonary Associates | Auburn | Maine | 04210 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Cooper University Hospital | Camden | New Jersey | 08103 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| New York University School of Medicine | New York | New York | 10016 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Department of Veterans Affairs, North Texas Health Care System | Dallas | Texas | 75216 | — |
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 NCT00125398, 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 Nov 6, 2008 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00125398 live on ClinicalTrials.gov.