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Sponsors and Collaborators: |
Eisai Medical Research Inc. Omnicare Clinical Research Bio Analytical Research Corporation MDS Pharma Services The Coghlan Group (Plasma Sample Supplies) HHI Clinical Research (Biostatistics) |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00209534 |
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.
Condition | Intervention | Phase |
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Colonoscopy Colon Polyps |
Drug: fospropofol disodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Two Part Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy |
Estimated Enrollment: | 200 |
Study Start Date: | January 2003 |
Study Completion Date: | February 2004 |
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | James Jones, MD,PharmD | Eisai Medical Research Inc. |
Study ID Numbers: | 3000-0207 |
Study First Received: | September 13, 2005 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00209534 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pathological Conditions, Anatomical Colonic Polyps Polyps |
Pathological Conditions, Anatomical Intestinal Polyps Colonic Polyps Polyps |