A Phase III, Randomized, Open-Label Study to Assess the Safety and Efficacy of AQUAVAN Injection Versus Midazolam HCl for Sedation in Patients Undergoing Colonoscopy Procedures
Sponsor study identifier
interventional
270
0 countries
N/A
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2004
Actual (reported)This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in patients undergoing colonoscopy as well as to assess the safety profile of AQUAVAN versus that of midazolam. Prior to the procedure, patients received fentanyl citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2004
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
December 2004
Actual (reported)September 13, 2005
Actual (reported)September 21, 2005
Actual (reported)The primary efficacy hypothesis was that AQUAVAN could sedate (≥3 consecutive Modified OAA/S scores ≤4) patients AND that they could complete the procedure successfully without requiring alternative sedative medication AND without requiring manual or
Secondary Efficacy Endpoints
Time to Fully Recovered from end of procedure
Time to Fully Alert from end of procedure
Change from baseline DSST score over time during recovery period
Duration and percent of time when a patient's Modified OAA/S score is at each level between the first dose of study medications and Fully Alert, inclusive
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
James Jones, MD,PharmD
Eisai Inc.
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
December 2004
Actual (reported)Contact the study team to confirm eligibility.
Last Updated
November 7, 2008
Record last verified: 2008-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: