An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Colonoscopy
A Phase 3, Randomized, Double-Blind, Dose-Controlled Study to Assess the Efficacy and Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal to Moderate Sedation in Patients Undergoing Colonoscopy
2 other identifiers
interventional
300
1 country
20
Brief Summary
Very often patients receive medication before a diagnostic procedure, like a colonoscopy, to help them relax and stay calm during the procedure. This is called procedural or minimal-to-moderate sedation. One product used for sedation is called propofol. AQUAVAN (fospropofol disodium) is made as a water soluble form of propofol allowing for rapid sedation during the entire procedure. This study is designed to test AQUAVAN for sedation during colonoscopy procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2006
Shorter than P25 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2005
CompletedFirst Posted
Study publicly available on registry
December 5, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedNovember 7, 2008
November 1, 2008
December 1, 2005
November 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sedation Success - 3 consecutive modified OAA/S scores of ≤4 after administration of sedative medication AND completing the procedure without requiring the use of alternative sedative medication AND without requiring manual or mechanical ventilation
Interventions
Eligibility Criteria
You may qualify if:
- Patient must be able to understand required assessments and procedures.
- Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study.
- Patient must be at least 18 years of age at the time of screening.
- If female, patient must be surgically sterile, postmenopausal, or not pregnant or lactating and must have been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and pre-dose.
- Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.
You may not qualify if:
- Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine.
- Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.
- Patient has a Mallampati Classification Score of 4; OR a Mallampati Classification Score of 3 AND a thyromental distance ≤4 cm, or for any other reason has a difficult airway, in the opinion of the Investigator.
- Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period Day 0.
- Patient has participated in an investigational drug study within 1 month prior to study start.
- Patient is unwilling to adhere to pre- and postprocedural instructions.
- Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.
- Patient for whom the use of midazolam HCl injection (midazolam) is contraindicated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (20)
Clinical Research Associates
Huntsville, Alabama, 35801, United States
UCSF-Fresno/University Medical Center
Fresno, California, 93702, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Rockford Gastroenterology Associates
Rockford, Illinois, 61107, United States
Welborn Clinic
Evansville, Indiana, 47713, United States
Indiana University Medical Center/Clarian Health Partner
Indianapolis, Indiana, 46202, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Maryland Digestive Diseases Center
Laurel, Maryland, 20707, United States
Shah Associates
Prince Frederick, Maryland, 20678, United States
Oakland Colon & Rectal Associates
Royal Oak, Michigan, 48067, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202, United States
Research Associates of New York (New York Gastroenterology Associates)
New York, New York, 10021, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
WestHills Gastroenterology Associates
Portland, Oregon, 97225, United States
Memphis Gastroenterology Group, PC
Germantown, Tennessee, 38138, United States
Gastrointestinal Institute
Nashville, Tennessee, 37203, United States
Alamo Research Center
San Antonio, Texas, 78215, United States
Spokane Digestive Disease Center
Spokane, Washington, 99204, United States
Wisconsin Center for Advance Research
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Jones, MD, PharmD
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 1, 2005
First Posted
December 5, 2005
Study Start
March 1, 2006
Study Completion
October 1, 2006
Last Updated
November 7, 2008
Record last verified: 2008-11