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
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy Colon Polyps||Drug: fospropofol disodium||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Two Part Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy|
|Study Start Date :||January 2003|
|Actual Study Completion Date :||February 2004|
- 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.
- 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.
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): NCT00209534
|Study Director:||James Jones, MD,PharmD||Eisai Inc.|