A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy
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ClinicalTrials.gov Identifier: NCT00209534 |
Recruitment Status
:
Completed
First Posted
: September 21, 2005
Last Update Posted
: December 4, 2009
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Sponsor:
Eisai Inc.
Collaborators:
Omnicare Clinical Research
Bio Analytical Research Corporation
MDS Pharma Services
The Coghlan Group (Plasma Sample Supplies)
HHI Clinical Research (Biostatistics)
Information provided by:
Eisai Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | September 13, 2005 | |||
First Posted Date ICMJE | September 21, 2005 | |||
Last Update Posted Date | December 4, 2009 | |||
Study Start Date ICMJE | January 2003 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
The primary efficacy objective was to determine the desired sedative dose/dose range and dosing paradigm of AQUAVAN, defined as one that consistently provided mild-to-moderate sedation (Modified OAA/S >=2 and <=4) in a majority of patients. | |||
Original Primary Outcome Measures ICMJE |
The primary efficacy objective was to determine the desired sedative dose/dose range and dosing paradigm of AQUAVAN, defined as one that consistently provided mild-to-moderate sedation (Modified OAA/S ³2 and £4) in a majority of patients. | |||
Change History | Complete list of historical versions of study NCT00209534 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Efficacy variables included: time to sedation, time to Fully Alert, time to Fully Recovered, time to Ready for Discharge, Modified OAA/S scores over time, number of doses and amount of AQUAVAN, and Patient and Physician Satisfaction Surveys. | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy | |||
Official Title ICMJE | A Phase 2, Two Part Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy | |||
Brief Summary | This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. 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. | |||
Detailed Description | Randomized, open label, multi-center, adaptive dose ranging study, in which several dose levels of AQUAVAN® Injection and fentanyl citrate injection will be investigated to produce a desired sedation level in patients undergoing elective colonoscopy. A desired sedative dose/dose range and dosing paradigm will be identified based on pre-set criteria using the Modified Observer's Assessment of Alertness/Sedation (OAA/S). The desired sedative dose/dose range and dosing paradigm of AQUAVAN® Injection is defined as one that consistently provides mild to moderate sedation (Modified OAA/S between 2 and 4 inclusive) in a majority of patients who are pre-medicated with fentanyl citrate injection. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: fospropofol disodium | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
200 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | February 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 85 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00209534 | |||
Other Study ID Numbers ICMJE | 3000-0207 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Eisai Inc. | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Eisai Inc. | |||
Verification Date | December 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |