A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.

Condition(s) targeted: Procedural Sedation

Intervention: AQUAVAN® (fospropofol disodium) Injection (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: MGI Pharma

Official(s) and/or principal investigator(s):
James B Jones, MD, PharmD, Study Director, Affiliation: MGI Pharma

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.

Official title: 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

Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome:

To assess the safety profile of AQUAVAN when used to provide minimal-to-moderate

sedation in patients undergoing minor surgical procedures.

Detailed description: This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Number of sites/patients: Approximately 18 sites and 125 patients. Inclusion Criteria: 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. Exclusion Criteria: 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 postprocedureal instructions. Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.

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

Chesapeake Research Group, LLC, Pasadena, Maryland 21122, United States

Chevy Chase Clinical Research, Chevy Chase, Maryland 20815, 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

Carolina Urologic Research, Myrtle Beach, South Carolina 29572, United States

Southern Orthopaedic Sports Medicine, Columbia, South Carolina 29204, United States

Dallas VA Medical Center, Dallas, Texas 75216, United States

Physicians' Research Options, Sandy, Utah 84070, United States

Starting date: May 2006
Ending date: December 2007
Last updated: December 19, 2007