A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
A Phase 3 Open-Label, Single Arm Study to Assess the Safety of AQUAVAN® (Fospropofol Disodium) Injection for Minimal-to-Moderate Sedation in Patients Undergoing Minor Surgical Procedures
1 other identifier
interventional
123
1 country
15
Brief Summary
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2006
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 16, 2006
CompletedFirst Posted
Study publicly available on registry
May 18, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
June 20, 2012
CompletedJune 20, 2012
May 1, 2012
May 16, 2006
March 1, 2012
May 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures
2 hours
Interventions
Eligibility Criteria
You may qualify if:
- Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures.
- Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) of 1996 authorization after receiving a full explanation of the extent and nature of the study.
- Patient must be at least 18 years of age and undergoing one of the specified minor surgical procedures 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 predose.
- 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 or opioid.
- 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 Principal Investigator.
- Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (15)
Precision Trials
Phoenix, Arizona, 85032, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Medical Research Institute, Inc.
Slidell, Louisiana, 70458, United States
Medical Research Institute
Slidell, Louisiana, 70458, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Chesapeake Research Group, LLC
Pasadena, Maryland, 21122, United States
St. Louis Women's Healthcare Group
Chesterfield, Missouri, 63017, United States
International Heart Institute of Montana
Missoula, Montana, 59802, United States
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, 29204, United States
Carolina Urologic Research
Myrtle Beach, South Carolina, 29572, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Physicians' Research Options
Sandy City, Utah, 84070, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eisai Medical Services
- Organization
- Eisai Inc
Study Officials
- STUDY DIRECTOR
James B Jones, MD, PharmD
Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 16, 2006
First Posted
May 18, 2006
Study Start
May 1, 2006
Study Completion
December 1, 2007
Last Updated
June 20, 2012
Results First Posted
June 20, 2012
Record last verified: 2012-05